A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations

GeneScience Pharmaceuticals (GenSci)

Status and phase

Completed

Phase 1

Conditions

Pediatric Growth Hormone Deficiency (PGHD)

Treatments

Drug: PEG-rhGH with present preparation

Drug: PEG-rhGH with new preparation

Study type

Interventional

Funder types

Industry

Identifiers

GenSci004-105

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.