A Study to Evaluate the Safety, Tolerability and Absorption to the Blood After Administration of Single and Multiple Doses of AZD8154 in Healthy Participants.
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD8154 Following Single and Multiple Ascending Dose Administration in Healthy Subjects.
1 other identifier
interventional
78
1 country
1
Brief Summary
This study is a Phase 1, first in human (FiH) study, consisting of 3 parts (Part 1, Part 2, and Part 3) in healthy male and female participants of non-childbearing potential, performed at a single study center. Part 1 of this study will be a randomized, single-blind, placebo-controlled, single ascending dose (SAD) in healthy male and female participants of non-childbearing potential. Six dose levels of AZD8154 are planned to be investigated. Depending on emerging data, 1 to 2 additional dose levels may be added at the discretion of the Sponsor. Furthermore, one dose level will be repeated using the same formulation of AZD8154 but with a larger particle size (Part 1 only). Part 2 of this study will be a single cohort, open-label, 2-period, study to compare a single inhaled dose of AZD8154 (small particle size) nebuliser suspension with a single IV dose of AZD8154. Part 3 will be a single blind placebo controlled, multiple ascending doses (MAD) sequential design study in healthy male and/or female subjects of non childbearing potential conducted at a single center. Part 3:Three (3) inhaled dose levels of AZD8154 are planned to be investigated. Depending on the emerging data, up to 2 additional inhaled dose levels may be added at the discretion of the Sponsor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Jul 2018
Typical duration for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2019
CompletedAugust 8, 2019
July 1, 2019
1 year
February 12, 2018
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (62)
Number of participants with adverse events (Part 1 & 2)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses; inhaled and intravenous (IV) administration of single doses to healthy participants.
From Day-1 up to follow-up visit (6 days post final dose).
Number of participants with adverse events (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From Day-1 up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in 12-lead digital electrocardiography (ECG) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
At Treatment period (Days 1 to 3).
Number of participants with abnormal findings in 12-lead digital ECG (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
At Treatment Periods 1 and 2 (Days 1 to 3).
Number of participants with abnormal findings in 12-lead digital ECG (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
At Treatment period (Days 1 to 15).
Number of participants with abnormal pulse rate (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to the treatment period (Day -1, Days 1 to 3)
Number of participants with abnormal pulse rate (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening (Days -28 to -2) up to follow-up visit (6 ± 1 days post-dose)
Number of participants with abnormal pulse rate (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening (Days-28 to -2) up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in telemetry (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
At Treatment Period (Days 1 to 3).
Number of participants with abnormal findings in telemetry (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
At Treatment Periods 1 (Days 1 to 3) and 2 (Days 1 to 3 and Day 4).
Number of participants with abnormal findings in telemetry (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
At Treatment Period (Days 1 to 15)
Number of participants with abnormal hematology (Part 1 & Part 2)
To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hematology (Part 3)
To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal blood pressure (systolic and diastolic) (Part 1 & Part 2)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to the treatment period (Day -1, Days 1 to 3)
Number of participants with abnormal blood pressure (systolic and diastolic) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in respiratory rate (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to the treatment period (Day -1, Days 1 to 3).
Number of participants with abnormal findings in respiratory rate (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal findings in respiratory rate (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal physical examination (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal physical examination (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal physical examination (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal findings in oral body temperature (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment period (Day -1, Days 1 to 3).
Number of participants with abnormal findings in oral body temperature (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to Treatment Periods 1 and 2.
Number of participants with abnormal findings in oral body temperature (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Forced expiratory volume in 1 second (FEV1) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 3.
FEV1 (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).
FEV1 (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Forced vital capacity (FVC) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 3.
FVC (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).
FVC (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Number of participants with abnormal electrolytes (Part 1)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal electrolytes (Part 2)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal electrolytes (Part 3)
To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal hemoglobin (Hb) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hemoglobin (Hb) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal hemoglobin (Hb) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal hematocrit (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal hematocrit (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal hematocrit (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular volume (MCV) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal platelet count (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal platelet count (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal platelet count (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal reticulocytes absolute count (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal reticulocytes absolute count (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal reticulocytes absolute count (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.
From screening up to follow-up visit (7-10 days post final dose).
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 1 & Part 2)
The DLCO assessment will be performed in Part 1 of the study. The DLCO assessments will be performed in Part 2, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the American thoracic society (ATS)/ European respiratory society (ERS) guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.
At Day -1, Days1 to 3 and follow-up visit (6 ± 1 days post-dose).
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 3)
The DLCO assessments will be performed in Part 2 and Part 3, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the ATS/ERS guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.
At Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).
Number of participants with abnormal clinical chemistry (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal clinical chemistry (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal clinical chemistry (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.
From screening up to follow-up visit (7-10 days post final dose).
Number of participants with abnormal urinalysis (Part 1)
To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.
From screening up to Treatment Period (Day-1, Days 1 to 3).
Number of participants with abnormal urinalysis (Part 2)
To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.
From screening up to follow-up visit (6 ± 1 days post-dose).
Number of participants with abnormal urinalysis (Part 3)
To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: protein, glucose, and blood.
From screening up to follow-up visit (7-10 days post final dose).
Secondary Outcomes (27)
Observed maximum plasma concentration (Cmax)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Terminal elimination rate constant (λz)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Area under the plasma concentration time curve from time zero to 24 hours after dosing (AUC(0 24))
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
- +22 more secondary outcomes
Study Arms (10)
SAD Cohort 1 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 1) and 2 participants will receive placebo.
SAD Cohort 2 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 2) and 2 participants will receive placebo.
SAD Cohort 3 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 3) and 2 participants will receive placebo.
SAD Cohort 4 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 4) and 2 participants will receive placebo.
SAD Cohort 5 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 5) and 2 participants will receive placebo. Participants in this Cohort will return for a second Treatment Period after a minimum washout period of 7 to 14 days. All 6 subjects will receive an inhaled dose of AZD8154 (large particle size).
SAD Cohort 6 (Part 1)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 6) and 2 participants will receive placebo.
Cohort 1 (Part 2)
EXPERIMENTALAll participants in this cohort will receive single IV dose of AZD8154 in Treatment Period 1 and then after washout period, will receive inhaled AZD8154 (small particle size) in Treatment Period 2.
MAD Cohort 1 (Part 3)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 8) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 8) or placebo once daily from Day 4 to Day 12.
MAD Cohort 2 (Part 3)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 9) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (Inhaled dose 9) or placebo once daily from Day 4 to Day 12.
MAD Cohort 3 (Part 3)
EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 10) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 10) or placebo once daily from Day 4 to Day 12.
Interventions
SAD Part 1; 6 cohorts which receive single dosing. One cohort is invited back for large particle administration. Part 2; 1 cohort which receives IV dose and then inhaled administration of AZD8154. MAD Part 3; 3 cohorts will receive inhaled multiple dosing. Additional doses are provisional and could be adjusted based on the emerging data from the previous dose by the safety review committee (SRC).
Eligibility Criteria
You may qualify if:
- Provision of signed and dated, written informed consent before any study specific procedures.
- Healthy male and/or female participants of non-childbearing potential aged 18 to 45 years (inclusive at the Screening Visit) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential, confirmed at Screening by fulfilling one of the following criteria: 3.1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels in the postmenopausal range. 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and weigh at least 60 kg and no more than 100 kg inclusive.
- Subject has a FEV1 ≥ 80% of the predicted value regarding age, height, gender and ethnicity at the Screening Visit.
You may not qualify if:
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Subject is immuno-compromised.
- History of diabetes, impaired fasting glucose, metabolic syndrome, hypertriglyceridemia or familial lipid disorders.
- Current or previous history of malignancy of any kind except cutaneous basal or squamous cell carcinoma successful treated with therapy.
- History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).
- Subject with latent or active tuberculosis (TB), as conformed by a positive QuantiFERON® - TB Gold test or as judged by the Investigator at the Screening Visit.
- History or presence of GI, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs, or bowel disorders not otherwise specified.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of the IMP.
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, defined as the following:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> the upper limit of the normal (ULN) laboratory range.
- Bilirubin \> 1.5 times the ULN laboratory range. 9.3. Absolute neutrophil count \< lower limit of normal (LLN). 9.4. Absolute lymphocyte count \< LLN. 9.5. Fasting plasma glucose \> ULN. 9.6. Triglycerides \> ULN.
- Any positive result at the Screening Visit for serum hepatitis B surface antigen (HBsAg) OR hepatitis B core antibodies (anti-HBc), hepatitis C antibody and human immunodeficiency virus (HIV).
- Abnormal vital signs, after 5 minutes supine rest, defined as any of the following:
- Systolic BP \< 90 mmHg or \> 140 mmHg. 11.2. Diastolic BP \< 50 mmHg or \> 90 mmHg. 11.3. Heart rate \< 50 or \> 90 beats per minute (bpm).
- Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead safety and any clinically important abnormalities in the 12-Lead dECG as considered by the Investigator that may interfere with the interpretation of QT interval corrected for heart rate using Fridericia's formula (QTcF) interval changes, including abnormal ST-T-wave morphology, particularly in the CSP defined primary lead for dECG analysis or left ventricular hypertrophy.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (1)
Research Site
Berlin, 14050, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
med. Rainard Fuhr, Dr
PAREXEL Early Phase Clinical Unit Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Part 1 of this study will be single-blind. Part 2 of this study will be open-label. Part 3 of this study will be single-blind.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2018
First Posted
February 19, 2018
Study Start
July 26, 2018
Primary Completion
July 29, 2019
Study Completion
July 29, 2019
Last Updated
August 8, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share