To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia
NCT04155645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2021-06-30
Summary
This is a Phase I study to assess the safety, tolerability and pharmacokinetics (PK), and pharmacodynamics (PD) of AZD8233, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD8233 in subjects with confirmed dyslipidemia with or without type 2 diabetes.
Conditions
Interventions
- DRUG
-
AZD8233 subcutaneous injection
Randomized subjects will receive SC dose of AZD8233 (dose 1, dose 2, and dose 3) injection.
- DRUG
-
Randomized subjects will receive SC dose of placebo injection.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
David Han, MD · PAREXEL Early Phase Clinical Unit-Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-21
- Primary Completion
- 2021-06-07
- Completion
- 2021-06-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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