A Phase 1 SAD study to assess safety, tolerability, and PK of AZD9550 in healthy participants
Research type
Research Study
Full title
A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
IRAS ID
1007049
Contact name
Sarah Illi
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-003308-34
Clinicaltrials.gov Identifier
Research summary
The trial is a single centre, single-blind trial in up to 64 healthy males and females (of non-childbearing potential) between the ages of 18 and 55 years. There will be up to 48 subjects in Part A, 8 subjects in Part B, and 8 subjects in Part C of the clinical trial. Part B will include Japanese subjects.
The medicine to be tested is this trial is a compound called AZD9550 being developed for the non-alcoholic steatohepatitis (NASH). Non-alcoholic steatohepatitis is a condition in which build-up of fat in the liver causes inflammation and damage in the liver.
The main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after intravenous (IV) and subcutaneous (SC) dosing of the clinical trial medicine in healthy subjects. 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:
- Screening period of a maximum 28 days
- In-house Treatment Period- admission on (Day -2) and be required to stay in the Unit for 10 days and 9 nights. Dosing will occur on Day 1 of the Treatment Period and have assessments performed until 7 days after dosing. Participants will be discharged from the Unit on Day 8
- Weekly Out-clinic Visits on Days 15, 22, 29 and 36 for safety assessments.
- A Follow up Visit 6 weeks (Day 43) after the dose of clinical trial medication
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/0012
Date of REC Opinion
10 Mar 2023
REC opinion
Further Information Favourable Opinion