NCT07016802

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study consists of two parts: the first part is the study in healthy volunteers, and the second part is the study in AGHD patients. The first part consists of two phases. Phase Ia is a single-ascending dose study in healthy male volunteers, and Phase Ib is a multiple-ascending dose study healthy male or female volunteers. The second part is Phase Ic，which is a a single-ascending dose study in AGHD patients. Phase Ia：GenSci134 was tested in 7 predetermined single dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male volunteers. Phase Ib：GenSci134 was tested in 3 predetermined multiple dose groups with placebo, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity in 36 healthy adult volunteers. Phase Ic :GenSci134 was tested in 2 predetermined dose groups with positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 16 AGHD patients.

Conditions

• Safety
• Tolerability
• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-11-25
• Completion: 2026-11-25
• First posted: 2025-06-12
• Last updated: 2026-04-14

Locations

1 site across 1 country: China