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Clinical trial

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

ID
Name
GenSci004-106
Description
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Trial arms
Trial start
2024-04-07
Estimated PCD
2024-05-31
Trial end
2024-11-30
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:
RRT, RTR, TRR
PEG-rhGH with present preparation (R)
A single subcutaneous injection of PEG-rhGH with present preparation
Arms:
RRT, RTR, TRR
Size
87
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
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': 87, 'type': 'ESTIMATED'}}
Updated at
2024-03-26

1 organization

1 product

1 indication

Organization
Changchun GeneScience Pharmaceutical
Product
PEG-rhGH
Indication
Pediatric Growth Hormone Deficiency