AZD8848 Single Ascending Dose Study
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
2 other identifiers
interventional
47
1 country
1
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2012
Longer than P75 for phase_1 healthy
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
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
June 6, 2016
CompletedJune 6, 2016
April 1, 2016
2.2 years
March 20, 2012
July 30, 2015
May 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events
Summary of number of subjects who had at least one adverse event
Screening up to Day 13
Summary for Lymphocytes Laboratory Results
Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)
Secondary Outcomes (6)
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)
On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)
On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)
On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Baseline, 24 Hours.
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
Baseline, 48 Hours
- +1 more secondary outcomes
Study Arms (2)
AZD8848
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
- Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Ability to produce sputum of good enough quality for assessment of biomarkers
You may not qualify if:
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 85 beats per minute)
- Prolonged QTcF \> 450 ms or shortened QTcF \< 340 ms or family history of long QT syndrome
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
- History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
- History of asthma or allergic rhinitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
Related Publications (1)
Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.
PMID: 26933507DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ajay Aggarwal
- Organization
- AstraZeneca R&D
Study Officials
- STUDY DIRECTOR
Ajay Aggarwal
AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA
- PRINCIPAL INVESTIGATOR
James Ritter, BA,MA D Phil,BM BCh,MRCP,FRCP
Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom
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
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 6, 2016
Results First Posted
June 6, 2016
Record last verified: 2016-04