Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.

Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Study ID
NCT07040930
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • GenSci120 — DRUG
    a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
  • Placebo — DRUG
    a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level

Study Details

This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.

Key Dates

First listed
Jun 27, 2025
Start date
Aug 1, 2025
Status verified
Jun 2025
Primary completion
Jul 5, 2026
Completion
Sep 20, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GenSci120
    Multiple ascending doses of GenSci120 administered subcutaneously (SC).
  • Experimental: Placebo
    Multiple ascending doses of placebo administered subcutaneously (SC).

Primary Outcome Measure

TEAEs [ Time Frame: 169 days ]

Central Contacts

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