Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D
NCT06829563 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2025-08-21
Summary
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) biomarkers in single ascending doses (SAD), food effect, and multiple doses studies of RZ-629 in healthy participants and T2D.
Conditions
Interventions
- DRUG
-
RZ-629
Administered orally
- DRUG
-
Administered orally
- OTHER
-
Fasted
Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout
- OTHER
-
Fed
Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout
Sponsors & Collaborators
-
Rezubio Pharmaceuticals Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-30
- Primary Completion
- 2025-12-20
- Completion
- 2026-02-20
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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