Status:
COMPLETED
A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Pediatric Growth Hormone Deficiency (PGHD)
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06135155
Start Date
November 6 2023
End Date
March 18 2024
Last Update
April 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
Chengdu, Sichuan, China, 610000