A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations

Study Overview
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Brief Summary
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The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.

Official Title
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A Single-center, Randomized, Double-blind, Parallel Design Phase Ⅰ Study to Compare the Pharmacokinetics of Two Different PEG-rhGH Preparations by Single Administration in Chinese Healthy Adult Male Subjects

Conditions
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Pediatric Growth Hormone Deficiency (PGHD)

Intervention / Treatment
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* Drug: PEG-rhGH with new preparation
* Drug: PEG-rhGH with present preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhGH with new preparation<br> | Drug: PEG-rhGH with new preparation<br>* A single subcutaneous injection of PEG-rhGH with new preparation<br>|
| Experimental: PEG-rhGH with present preparation<br> | Drug: PEG-rhGH with present preparation<br>* A single subcutaneous injection of PEG-rhGH with present preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation. |  | 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 | 
| 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 | 
| Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment) |  | 0 hours -168 hours | 
| Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment) |  | 0 hours -168 hours |