NCT06135168CompletedPhase 1
A Single-center, Randomized, Open-label, Parallel Study to Compare the Pharmacokinetics of Two Polyethylene Glycol Recombinant Human Growth Hormone With Different Preparations by Single Subcutaneous Injection in Chinese Healthy Adult Male Subjects
Changchun GeneScience Pharmaceutical Co., Ltd.1 site in 1 country60 target enrollmentStarted: October 31, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (Peak Plasma Concentration (Cmax)) of PEG-rhGH with present and new preparation
Study Overview
Brief Summary
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
PEG-rhGH with new preparation
Experimental
Intervention: PEG-rhGH with new preparation (Drug)
PEG-rhGH with present preparation
Experimental
Intervention: PEG-rhGH with present preparation (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (Peak Plasma Concentration (Cmax)) of PEG-rhGH with present and new preparation
Time Frame: 0 hours -168 hours
Pharmacokinetics (The area under the concentration time curve from time zero to time infinity(AUC0-∞)) of PEG-rhGH with present and new preparation
Time Frame: 0 hours -168 hours
Pharmacokinetics (the area under the concentration-time curve from time zero to time t (AUC0-t))of PEG-rhGH with present and new preparation
Time Frame: 0 hours -168 hours
Secondary Outcomes
- Safety and tolerability （Number of participants with treatment-related adverse events）(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 Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)(Day1 0 hours and Day 8 168 hours)
- Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)(Day1 0 hours and Day 8 168 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 and/or Vital Signs That Are Related to Treatment)(Day1 0 hours and Day 8 168 hours)
Investigators
Study Sites (1)
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