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Phase 1 Clinical Study of GenSci164 Injection

NCT07790783 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-08-27

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single subcutaneous injection in healthy adult participants in China.

Conditions

  • Healthy Adult Trial Participants

Interventions

DRUG

GenSci164 Injection

6 dose cohorts

DRUG

Placebo

6 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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2027-10-25
Completion
2028-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790783 on ClinicalTrials.gov