A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects
NCT06548932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2024-08-16
Summary
This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
GZR33 Injection
A single dose
- DRUG
-
GZR101 Injection
A single dose
- DRUG
-
A single dose
Sponsors & Collaborators
-
Gan and Lee Pharmaceuticals, USA
lead INDUSTRY
Principal Investigators
-
Clinical Transparency · Gan & Lee Pharmaceuticals.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-30
- Primary Completion
- 2023-02-24
- Completion
- 2023-02-24
Countries
- China
Study Locations
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