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
NCT04142424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2021-11-26
Summary
This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.
Conditions
- Metabolic Disorders
- Non-alcoholic Steatohepatitis
Interventions
- DRUG
-
AZD2693
Subjects will receive SC injection of AZD2693 as per the arms they are randomized.
- DRUG
-
Subjects will receive SC injection of placebo matched to AZD2693, as per the arms they are randomized.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
David Han, MD · Parexel Early Clinical Unit - Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-10-28
- Primary Completion
- 2021-11-12
- Completion
- 2021-11-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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