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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pegylated-Somatropin; Drug: YPEG-Somatropin

• Registration Number: NCT01339182
• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2011-01
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pegylated-Somatropin, 10mcg/kg	Pegylated-Somatropin	-
Pegylated-Somatropin, 30mcg/kg	YPEG-Somatropin	-
Pegylated-Somatropin, 60mcg/kg	YPEG-Somatropin	-
Pegylated-Somatropin, 120mcg/kg	YPEG-Somatropin	-
Pegylated-Somatropin, 200mcg/kg	YPEG-Somatropin	-

Primary Outcome Measures

Name	Time	Method
Measurement of the IGF-1 levels for pharmacodynamics study	baseline, one week after initiation of the control drug and two weeks after initiation of the study drug

Secondary Outcome Measures

Name	Time	Method
Measuring the drug levels in blood samples	baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Measurement of IGFBP-3 levels for pharmacodynamic study	baseline, one week after initiation of the control drug and two weeks after initiation of the study drug

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China