A Phase 1 double-blind, SAD study to assess safety, tolerability, PK and PD of AZD6912 in HVs
Research type
Research Study
Full title
A Phase I, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants
IRAS ID
1008217
Contact name
Sarah Illi
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
The trial is a single centre, double-blind trial in up to approximately 72 healthy males and females between the ages of 18 and 50 years. Six dose ascending cohorts with 8 participants each are planned, 3 additional cohorts, including Japanese participants, may be considered depending on emerging safety, PK and PD data.
The medicine to be tested is this trial is a compound called AZD6912 being developed for the Rheumatoid Arthritis (RA). RA is multi-systemic inflammatory condition characterised by inflammatory arthritis of peripheral synovial joints.
The main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after subcutaneous (SC) dosing of the clinical trial medicine in healthy participants. The clinical trial will also investigate how the clinical trial medicine is taken up, metabolised (chemically broken down), distributed through the body and excreted (removed from the body). The clinical trial will also try to understand if the body develops a natural defence against the clinical trial medicine by producing antibodies against the clinical trial medicine (antibodies are proteins produced by the human body that help fight off foreign substances entering your body).
The trial will comprise of:
- A screening period of maximum 70 days
- A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 and be discharged on Day 11.
- Weekly outpatient visits from Day 15, bi-weekly visits from Day 43, 4-weekly visits from Day 99 and 6-weekly visits from Day 155. Additional Follow-up Visits may be required until CAP activity has returned to within the normal reference range.This a first-in-human trial, which means that this is the first time that this medicine will be given to humans. Up to now, it has only been tested in animals.
REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0630
Date of REC Opinion
10 Nov 2023
REC opinion
Further Information Favourable Opinion