A Bioequivalence Study of Two Different PEG-rhGH Preparations.

A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 87
• 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
      • 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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRR; Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R)	Drug: PEG-rhGH with new preparation (T); A single subcutaneous injection of PEG-rhGH with new preparation; Drug: PEG-rhGH with present preparation (R); A single subcutaneous injection of PEG-rhGH with present preparation
Experimental: RTR; Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)	Drug: PEG-rhGH with new preparation (T); A single subcutaneous injection of PEG-rhGH with new preparation; Drug: PEG-rhGH with present preparation (R); A single subcutaneous injection of PEG-rhGH with present preparation
Experimental: RRT; Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)	Drug: PEG-rhGH with new preparation (T); A single subcutaneous injection of PEG-rhGH with new preparation; Drug: PEG-rhGH with present preparation (R); 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 -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation	0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation	0 hours -192hours post-administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability（Number of participants with treatment-related adverse events）	up to approximately 83 days

Other Outcome Measures

Outcome Measure	Time Frame
Anti-drug antibody (Number of Participants with positive ADA)	0 hours -192 hours post-administration

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GenSci004-106

Drug and device information, study documents

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