A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 48
Summary
- Conditions
- Metabolic Disorders
- Non Alcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects in this study will be categorized as follows: Overweight/mildly obese, but otherwise healthy subjects: There will be 6 cohorts, with 8 subjects in each cohort. Japanese and Chinese subjects: There will be 2 cohorts for Japanese subjects, and one cohort for Chinese subjects, with 8 subjects in each cohort. Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This is a single center study, and approximately 64 overweight/mildly obese but otherwise healthy male and female subjects, and up to 16 healthy Japanese subjects and 8 healthy Chinese (all of non-childbearing potential) will be enrolled into this study. Study will consist of following planned cohor...
This is a single center study, and approximately 64 overweight/mildly obese but otherwise healthy male and female subjects, and up to 16 healthy Japanese subjects and 8 healthy Chinese (all of non-childbearing potential) will be enrolled into this study. Study will consist of following planned cohorts: Eligible healthy subjects will be divided in 6 cohorts, each consisting of 8 subjects, within each cohort, 6 subjects will receive AZD2693 at dose level 1 and 2 subjects will receive placebo. Dosing for each ascending dose cohort will proceed with 2 subjects in a sentinel cohort, such that 1 subject will be randomized to receive placebo and 1 subject will be randomized to receive AZD2693. Eligible healthy Japanese and Chinese subjects will be divided as two cohorts of Japanese subjects, and one cohort of Chinese subjects. Each cohort will consist of 8 subjects. Within each cohort, 6 subjects will receive AZD2693 and 2 subjects will receive placebo. Depending on emerging data, up to 2 additional cohorts may be added to test additional dose levels based on Sponsor's decision. Full study will comprise of following periods: Screening period of maximum 28 days. A Dosing Session during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day -1) until at least 3 days after IMP administration with discharge on Day 4. A Follow-Up Period of 16 weeks that will consist of 9 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 1, 2, 4, 6, 8, 10, 12, 14, and 16 weeks post dose.
Tracking Information
- NCT #
- NCT04142424
- Collaborators
- Parexel
- Investigators
- Principal Investigator: David Han, MD Parexel Early Clinical Unit - Los Angeles
Get Well Soon