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Completed

NCT Number: NCT01339182

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegylated-Somatropin

Drug

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.

YPEG-Somatropin

Drug

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.

Primary outcomes

  1. Measurement of the IGF-1 levels for pharmacodynamics study

    Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug

Secondary outcomes

  1. Measuring the drug levels in blood samples

    Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug

  2. Measurement of IGFBP-3 levels for pharmacodynamic study

    Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Peking Union Medical College Hospital

Registry information

Official study title

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

Acronym: Somatropin

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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