A Phase I, Randomized, Single-blind, Placebo-controlled, 2-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4916 Following Single- and Multiple-ascending-dose Administration to Healthy Adult Volunteers (Including Japanese and Chinese Healthy Volunteers)
AstraZeneca
Summary
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Description
This is a single-blind, placebo-controlled study conducted at a single clinical unit. The study will comprise of: * Part 1: Single ascending dose (SAD) part (part 1a) and a Multiple ascending dose (MAD) part (part 1b), both in global participants. * Part 2: SAD part (part 2a) and a MAD part (part 2b) specifically for Japanese and Chinese participants only.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Main Inclusion Criteria: * Healthy male and female participants with suitable veins for cannulation or repeated venipuncture. * All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective contraception. * Have a Body Mass Index between 18 and 30 kg/m2 inclusive and weigh at least 45 kg at Screening. * Part 2, Japanese participants only: Japanese participants must have been born in Japan, have 2 Japanese biological parents and 4 Japanese grandparents (as confirmed by the interview), and m…
Interventions
- DrugAZD4916
AZD4916 will be administered as oral solution.
- OtherPlacebo
Placebo will be administered as oral solution.
Locations (2)
- Research SiteGlendale, California
- Research SiteHarrow