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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborator: Peking Union Medical College Hospital

Criteria

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.