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A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)

NCT07016802 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-14

No results posted yet for this study

Summary

To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.

Conditions

  • Safety
  • Tolerability
  • Adult Growth Hormone Deficiency

Interventions

DRUG

GenSci134

only one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned.

DRUG

Placebo

only one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned.

DRUG

Recombinant Human Growth Hormone Injection (Norditropin®)

A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongyang LIU, PHD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2026-11-25
Completion
2026-11-25

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 NCT07016802 on ClinicalTrials.gov