A Bioequivalence Study of Two Different PEG-rhGH Preparations.
Phase 1
Completed
- Conditions
- Pediatric Growth Hormone Deficiency (PGHD)
- Interventions
- Drug: PEG-rhGH with new preparation (T)Drug: PEG-rhGH with present preparation (R)
- Registration Number
- NCT06331026
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 87
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
- CROSSOVER
- Arm && Interventions
Group Intervention Description RRT PEG-rhGH with new preparation (T) Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T) TRR PEG-rhGH with present preparation (R) Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R) RTR PEG-rhGH with present preparation (R) Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R) RTR PEG-rhGH with new preparation (T) Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R) TRR PEG-rhGH with new preparation (T) Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R) RRT PEG-rhGH with present preparation (R) Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety and tolerability（Number of participants with treatment-related adverse events） up to approximately 83 days
Trial Locations
- Locations (1)
Chengdu Xinhua Hospital
🇨🇳Chengdu, Sichuan, China