Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics

NCT04585009 | Completed Phase 1 Results

• 1 other identifier: 213497
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

First time in human; Stable asthmatics; GSK3923868; Inhalation powder; Phosphatidylinositol 4-kinase beta

Outcome Measures

Primary Outcomes (16)

• Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-1 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.

  Up to Day 43

• Part A, Cohort 2: Number of Participants With AEs and SAEs

  AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-2 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.

  Up to Day 43

• Part B: Number of Participants With AEs and SAEs

  AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part B, Cohort-3 and 4 (repeat dose) of the study were reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).

  Up to Day 28

• Part C: Number of Participants With AEs and SAEs

  AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part C, Cohort-5 (repeat dose) of the study were reported.

  Up to Day 21

• Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters

  The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters

  The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters

  The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 18

• Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters

  The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 8

• Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings

  Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-1 were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings

  Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-2 were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings

  Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 18

• Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings

  Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-5 were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 8

• Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Spirometry Measurements

  Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Spirometry Measurements

  Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 2 in each treatment period

• Part B: Number of Participants With Clinically Significant Changes in Spirometry Measurements

  Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) up to Day 18

• Part C: Number of Participants With Clinically Significant Changes in Spirometry Measurements

  Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.

  From start of the treatment (Day 1) to Day 8

Secondary Outcomes (10)

• Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-t])

  Up to Day 2 in each treatment period

• Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf])

  Up to Day 2 in each treatment period

• Part A, Cohort 1 and 2: Maximum Observed GSK3923868 Plasma Concentration (Cmax)

  Up to Day 2 in each treatment period

• Part A, Cohort 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax)

  Up to Day 2 in each treatment period

• Part B, Cohort 3 and 4: AUC From Time Zero (Predose) to Time Tau (AUC [0-tau]) (Tau=24hours for Once a Day Dosing Regimen) of GSK3923868

  Up to Day 14

Study Arms (11)

Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Device: Monodose RS01

Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Drug: Matching placebo; Device: Monodose RS01

Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg

EXPERIMENTAL

Healthy participants will receive single ascending doses of GSK3923868 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.

Drug: GSK3923868; Device: Monodose RS01

Cohort 3: Participants receivings repeated doses of GSK3923868

EXPERIMENTAL

Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days

Drug: GSK3923868; Device: Monodose RS01

Cohort 4: Participants receiving repeat doses of GSK3923868

EXPERIMENTAL

Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days

Drug: GSK3923868; Device: Monodose RS01

Cohort 5: Participants receiving repeat doses of GSK3923868

EXPERIMENTAL

Participants with stable asthma will receive a planned repeat dosing of 3000 mcg (six capsules) GSK3923868 daily for 7 days

Drug: GSK3923868; Device: Monodose RS01

Interventions

GSK3923868 DRUG

GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo; Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg; Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg; Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo; Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg; Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg; Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg; Cohort 3: Participants receivings repeated doses of GSK3923868; Cohort 4: Participants receiving repeat doses of GSK3923868; Cohort 5: Participants receiving repeat doses of GSK3923868; Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg

Matching placebo DRUG

Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo; Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg; Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo; Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg; Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg; Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg

Monodose RS01 DEVICE

Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo; Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg; Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg; Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo; Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg; Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg; Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg; Cohort 3: Participants receivings repeated doses of GSK3923868; Cohort 4: Participants receiving repeat doses of GSK3923868; Cohort 5: Participants receiving repeat doses of GSK3923868; Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 50 years of age inclusive, at the time of signing the informed consent.
• Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, laboratory tests and cardiac monitoring.
• Body weight at least 50.0 kilograms (kg) (110 pounds \[lbs\]) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per meter square (kg/m\^2) (inclusive).
• Male Participants: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of study intervention: Refrain from donating sperm. Plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remaining abstinent OR must agree to use contraception as detailed below when having sexual intercourse with a woman of childbearing potential who is not currently pregnant: Agree to use a male condom AND female partner to use an additional highly effective contraceptive method with a failure rate of \< 1 percent per year. The participant should also be advised of the benefit for a female partner as a condom may break or leak.
• Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a woman of non-childbearing potential (WONCBP).
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
• Between 18 and 50 years of age inclusive, at the time of signing the informed consent.
• Participants who are otherwise healthy (other than the acceptable condition of asthma and other mild atopic diseases, including allergic rhinitis and atopic dermatitis) as determined by medical evaluation based on screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, laboratory tests and cardiac monitoring.
• A physician diagnosis of asthma (as defined by the Global Initiative for Asthma \[GINA\], 2020 guidelines) at least 6 months before screening. The reason for diagnosis of asthma should be documented in the participant's source data, including relevant history.
• A screening pre-bronchodilator FEV1 \>= 65 percent predicted normal value.
• Positive bronchodilator reversibility test defined as an increase in FEV1 of \> 12 percent and \> 200 milliliter (mL) from Baseline, 10 to 15 minutes after administration of 400 micrograms (μg) salbutamol (or equivalent).
• Participants with maintained control of their asthma using the permitted medications: short-acting beta agonist (SABA) use only (n=8 participants) and regular treatment with inhaled corticosteroid (ICS) or ICS/long-acting beta agonist (LABA) (including use of Leukotriene Receptor Agonist \[LTRA\]) (n=8 participants).
• Body weight at least 50.0 kg (110 lbs) and BMI within the range 18.5 to 32.0 kg/m\^2 (inclusive).
• Male Participants: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remaining abstinent OR must agree to use contraception as detailed below when having sexual intercourse with a woman of childbearing potential who is not currently pregnant: Agree to use a male condom AND female partner to use an additional highly effective contraceptive method with a failure rate of \< 1 percent per year. The participant should also be advised of the benefit for a female partner as a condom may break or leak.
• Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a WONCBP.

You may not qualify if:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
• Alanine transaminase (ALT) and Aspartate Aminotransferase (AST) above upper limit of normal (ULN).
• Total Bilirubin above ULN (isolated bilirubin above ULN is acceptable if total bilirubin is fractionated and direct bilirubin \<35 percent).
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• QTcF \> 450 milliseconds (msec) at screening visit based on the average of triplicate ECGs.
• Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
• Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization).
• Signs and symptoms suggestive of COVID-19.
• Past or intended use of over-the-counter or prescription medication, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days before the first dose of study intervention, unless in the opinion of the Investigator and the GlaxoSmithKline (GSK) Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety.
• Participation in this study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days.
• Exposure to more than 4 new chemical entities within 12 months before the first dosing day.
• Current enrolment or past participation in a clinical trial and has received an investigational product within the following time period before the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• FEV1 and FVC is \< 80 percent predicted normal value.
• Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
• Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A will be a single ascending dose escalation study consisting of two sequential cross-over cohorts (Cohorts 1 and 2) in healthy participants. Part B is a repeat dose study consisting of two parallel cohorts (Cohort 3 and 4) in healthy participants. Part C is a repeat dose study consisting of one cohort (Cohort 5) in participants with asthma.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 14, 2020
• Study Start: October 12, 2020
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (1)