Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults
NCT07638800 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2026-06-10
Summary
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics of GenSci155 after a single or multiple intravenous injection in healthy Chinese adult trial participants.
Conditions
- Healthy Adult Trial Participants
Interventions
- DRUG
-
GenSci155 Injection
Part 1 consists of a total of 6 dose cohorts,Part 2 consists of a total of 3 dose cohorts
- DRUG
-
Part 1 consists of a total of 6 dose cohorts,Part 2 consists of a total of 3 dose cohorts
Sponsors & Collaborators
-
Changchun GeneScience Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-28
- Primary Completion
- 2027-04-16
- Completion
- 2027-07-28
Countries
- China
Study Locations
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