A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations

Phase 1

Completed

• Conditions: Pediatric Growth Hormone Deficiency (PGHD)
• Interventions: Drug: PEG-rhGH with new preparation; Drug: PEG-rhGH with present preparation

• Registration Number: NCT06135168
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-31
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-12
• Study First Posted: 2023-11-18
• Primary Completion: 2023-11-29
• Study Completion: 2024-03-18
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Healthy male aged ≥18 years old and≤45 years old;
• The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
• Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria

• Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
• Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
• Subjects with severe infection, severe trauma, or major surgery prior to screening;
• Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
• Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
• Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rhGH with new preparation	PEG-rhGH with new preparation	-
PEG-rhGH with present preparation	PEG-rhGH with present preparation	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (Peak Plasma Concentration (Cmax)) of PEG-rhGH with present and new preparation	0 hours -168 hours
Pharmacokinetics (The area under the concentration time curve from time zero to time infinity(AUC0-∞)) of PEG-rhGH with present and new preparation	0 hours -168 hours
Pharmacokinetics (the area under the concentration-time curve from time zero to time t (AUC0-t))of PEG-rhGH with present and new preparation	0 hours -168 hours

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability （Number of participants with treatment-related adverse events）	0 hours -168 hours
Pharmacokinetics (half-life (t1/2)) of PEG-rhGH with present and new preparation.	0 hours -168 hours
Pharmacokinetics (terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation.	0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)	Day1 0 hours and Day 8 168 hours
Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)	Day1 0 hours and Day 8 168 hours
Pharmacokinetics (the time to reach the peak drug concentration(Tmax) of PEG-rhGH with present and new preparation.	0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal Laboratory Values and/or Vital Signs That Are Related to Treatment)	Day1 0 hours and Day 8 168 hours

Trial Locations

Locations (1)

Chengdu Xinhua Hospital affiliated to North Sichuan Medical College; 🇨🇳 Chengdu, Sichuan, China