NCT01339182

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pegylated-Somatropin	Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.
DRUG	YPEG-Somatropin	Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.
DRUG	YPEG-Somatropin	Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.
DRUG	YPEG-Somatropin	Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.
DRUG	YPEG-Somatropin	Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-04-20
• Last updated: 2013-02-04

Locations

1 site across 1 country: China