Clinical trial NCT06385145: A Bioavailability Study of Two Different PEG-rhGH Preparations.
Official title: A Randomized, Open-label, Single Dose, 2-period Crossover Bioavailability Study of Two Different Polyethylene Glycol Recombinant Human Growth Hormone(PEG-rhGH) Preparations 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: 2024-04-25
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations.


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 -192 hours post-administration
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -192 hours post-administration
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -192hours post-administration
measure: Safety and tolerability (Number of participants with treatment-related adverse events)
timeFrame: up to approximately 30 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation
timeFrame: 0 hours -192 hours post-administration
measure: Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation
timeFrame: 0 hours -192 hours post-administration
measure: Anti-drug antibody (Number of Participants with positive ADA)
timeFrame: 0 hours -192 hours post-administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital
state: Sichuan
Study officials:
References: