RecruitingPhase 1NCT07016802

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

A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency


Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

64 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GenSci134, a drug called Placebo, and others for people with adult growth hormone deficiency, safety, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGenSci134

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

DRUGPlacebo

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

DRUGRecombinant Human Growth Hormone Injection (Norditropin®)

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


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT07016802


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