A Bioequivalence Study of Two Different PEG-rhGH Preparations.

A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults

NCT06331026•Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Eligibility

Age

18 - 45 years

Sex

MALE

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.

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

April 9, 2024

Primary Completion Date

July 15, 2024

Completion Date

August 28, 2024

Last Updated

November 8, 2024

Enrollment

ACTUAL participants

Conditions

Pediatric Growth Hormone Deficiency (PGHD)

Interventions

PEG-rhGH with new preparation (T)

DRUG

PEG-rhGH with present preparation (R)

DRUG