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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01339182

Acronym

Somatropin

Enrollment

Registered

2011-04-20

Start date

2011-01-31

Completion date

2012-08-31

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

somatropin, PK, PD, male, pharmacokinetics, pharmacodynamics, safety

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.

Interventions

DRUGPegylated-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.

DRUGYPEG-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026