Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

September 15, 2028

Study Completion Date

December 23, 2028

Conditions
Growth Hormone Deficiency in ChildrenGrowth Hormone Deficiency (GHD)Growth Hormone
Interventions
DRUG

GB08

"In Phase II trial, eligible PGHD patients will receive GB08 0.4mg/kg, 0.8mg/kg, or 1.2mg/kg subcutaneous injection, once a week for 24 weeks.~In Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II."

DRUG

Norditropin NordiFlex

Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)

Trial Locations (16)

130021

The First Hospital of Jilin University, Changchun

215000

Suzhou University Children's Hospital, Suzhou

276000

Linyi Maternal and Child Health Hospital, Linyi

310014

Zhejiang Provincial People's Hospital, Hangzhou

310051

Children's Hospital of Zhejiang University School of Medicine, Hangzhou

315010

Ningbo Women's and Children's Hospital, Ningbo

330006

Jiangxi Children's Hospital, Nanchang

337000

Pingxiang Maternal and Child Health Hospital, Pingxiang

361000

Xiamen Maternal and Child Health Hospital, Xiamen

430016

Wuhan Children's Hospital, Wuhan

453003

The Third Affiliated Hospital of Xinxiang Medical University, Xinxiang

473000

Nanyang Central Hospital, Nanyang

The First Affiliated Hospital of Nanyang Medical College, Nanyang

610017

Chengdu Women's and Children's Central Hospital, Chengdu

620010

Meishan People's Hospital, Meishan

644000

The Second People's Hospital of Yibin, Yibin

All Listed Sponsors
lead

Shenzhen Kexing Pharmaceutical Co., Ltd.

NETWORK

NCT07126288 - Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter