Clinical trial NCT06135155: A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric Growth Hormone Deficiency (PGHD)
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -168 hours
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-∞)) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -168 hours
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time t (AUC0-t )) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -168 hours
Secondary outcomes:
measure: Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation.
timeFrame: 0 hours -168 hours
measure: Pharmacokinetics (Half-life (t1/2)) of PEG-rhGH with present and new preparation.
timeFrame: 0 hours -168 hours
measure: Pharmacokinetics (Terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation.
timeFrame: 0 hours -168 hours
measure: Safety and tolerability（Number of participants with treatment-related adverse events）
timeFrame: 0 hours -168 hours
measure: Safety and tolerability (Number of Participants with Abnormal Vital Signs That Are Related to Treatment)
timeFrame: 0 hours -168 hours
measure: Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)
timeFrame: 0 hours -168 hours
measure: Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)
timeFrame: 0 hours -168 hours
Other outcomes:
measure: Anti-drug antibody (Number of Participants with positive ADA)
timeFrame: 0 hours -168 hours
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
state: Sichuan
Study officials:
References: