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

Information source: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pegylated-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Xiamen Amoytop Biotech Co., Ltd.

Official(s) and/or principal investigator(s):
Hu Pei, Ph.D, Principal Investigator, Affiliation: Peking Union Medical College Hospital


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.

Clinical Details

Official title: A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Measurement of the IGF-1 levels for pharmacodynamics study

Secondary outcome:

Measuring the drug levels in blood samples

Measurement of IGFBP-3 levels for pharmacodynamic study


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

Peking Union Medical College Hospital, Beijing, Beijing 100032, China
Additional Information

Starting date: January 2011
Last updated: January 31, 2013

Page last updated: August 23, 2015

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