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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants

Non-alcoholic Steatohepatitis Clinical Trial

Official 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

Clinical Trial Summary

This is 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.

Clinical Trial Description

This study will be a Phase I, First-In-Human (FIH), randomised, single-blind, placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre. The study consists of 3 parts: - Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy participants. - Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent. - Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants. The study will comprise of: - A Screening Period of maximum 28 days. - A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before (Day -2) investigational medicinal product (IMP]) administration (Day 1) until at least 7 days (168 hours; Day 8) after IMP administration. - Weekly out-clinic visits on Days 15, 22, 29, and 36. - A Follow-up Visit 6 weeks (Day 43) after the IMP dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05848440
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date May 2, 2023
Completion date November 13, 2023
View Details
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