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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pegylated-Somatropin; Drug: YPEG-Somatropin; Drug: YPEG-Somatropin; Drug: YPEG-Somatropin; Drug: YPEG-Somatropin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegylated-Somatropin, 10mcg/kg	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.
Experimental: 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, 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.
Experimental: 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, 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.
Experimental: 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, 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.
Experimental: Pegylated-Somatropin, 200mcg/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborators: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Hu Pei, Ph.D, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; PK; male; somatropin; pharmacodynamics; PD
• Other Study ID Numbers: TB1010GH