Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers

Xiamen Amoytop Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: YPEG-Somatropin

Drug: Pegylated-Somatropin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01339182

TB1010GH

Details and patient eligibility

About

This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.

Enrollment

36 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects
Age(yr)between 18 and 45
Body mass index(BMI)between 20 and 28
sign informed consent

Exclusion criteria

Known hypersensitivity to somatropin or any other components of the study drug
Organic lesion in heart, liver, kidney or any other major organs
History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
Alcoholic, smokers or drug abusers
Blood donation, or massive blood loss due to injury or surgery within 3 months
Other conditions which in the opinion of the investigator preclude enrollment into the study.