A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations

A Single-center, Randomized, Double-blind, Parallel Design Phase Ⅰ Study to Compare the Pharmacokinetics of Two Different PEG-rhGH Preparations by Single Administration in Chinese Healthy Adult Male Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Growth Hormone Deficiency (PGHD)
• Intervention / Treatment: Drug: PEG-rhGH with new preparation; Drug: PEG-rhGH with present preparation

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jingsi LI; Phone Number: +86 18301941524; Email: lijingsi@genscigroup.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
      • Contact: Xiaolan Yong, Doctor; Phone Number: +86-28-60212136; Email: yongxlan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhGH with new preparation	Drug: PEG-rhGH with new preparation; A single subcutaneous injection of PEG-rhGH with new preparation
Experimental: PEG-rhGH with present preparation	Drug: PEG-rhGH with present preparation; A single subcutaneous injection of PEG-rhGH with present preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation	0 hours -168 hours
Pharmacokinetics (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 (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

Outcome Measure	Time Frame
Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation.	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 treatment-related adverse events）	0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal Vital Signs That Are Related to Treatment)	0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)	0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)	0 hours -168 hours

Other Outcome Measures

Outcome Measure	Time Frame
Anti-drug antibody (Number of Participants with positive ADA)	0 hours -168 hours

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2023
• Primary Completion (Estimated): December 9, 2023
• Study Completion (Estimated): January 6, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GenSci004-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No