Pediatric Growth Hormone Deficiency (PGHD)
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
Interventions
A single subcutaneous injection of PEG-rhGH with new preparation
A single subcutaneous injection of PEG-rhGH with present preparation
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Area under the concentration-time curve from time zero to time t (AUC0-t )) of PEG-rhGH with present and new preparation | 0 hours -168 hours |
| Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation | 0 hours -168 hours |
| Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-∞)) of PEG-rhGH with present and new preparation | 0 hours -168 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability（Number of participants with treatment-related adverse events） | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal Vital Signs That Are Related to Treatment) | 0 hours -168 hours |
| Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment) | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment) | 0 hours -168 hours |
| Pharmacokinetics (Half-life (t1/2)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours |
| Pharmacokinetics (Terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours |
Other
| Measure | Time frame |
|---|---|
| Anti-drug antibody (Number of Participants with positive ADA) | 0 hours -168 hours |
Countries
China
Outcome results
None listed