NCT07260500

A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Polyethylene Glycol Recombinant Human Growth Hormone Injection in Short Children Born Small for Gestational Age (SGA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.

Conditions

• Short Stature Children Born Small for Gestational Age (SGA)

Interventions

Type	Name	Description
DRUG	PEG-rhGH Injection	Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..
DRUG	hGH Injection	Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-12-23
• Completion: 2027-04-30
• First posted: 2025-12-03
• Last updated: 2026-02-17

Locations

1 site across 1 country: China