Clinical trial

A Randomized, Open-label, Single Dose, 2-period Crossover Bioavailability Study of Two Different Polyethylene Glycol Recombinant Human Growth Hormone(PEG-rhGH) Preparations in Chinese Healthy Adult Male Subjects

NCT06385145

Name

GenSci004-107

Description

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

Trial arms

Trial start

2024-05-08

Estimated PCD

2024-07-13

Trial end

2024-12-26

Status

Not yet recruiting

Phase

Early phase I

Treatment

PEG-rhGH with new preparation (T)

A single subcutaneous injection of PEG-rhGH with new preparation

Arms:

RT, TR

PEG-rhGH with present preparation (R)

A single subcutaneous injection of PEG-rhGH with present preparation

Arms:

RT, TR

Size

Primary endpoint

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

Safety and tolerability (Number of participants with treatment-related adverse events)

up to approximately 30 days

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

Updated at

2024-04-25

1 organization

1 product

1 indication

Organization

Changchun GeneScience Pharmaceutical

Product

PEG-rhGH

Indication

Pediatric Growth Hormone Deficiency