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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2011
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 4, 2013
December 1, 2010
1.6 years
April 14, 2011
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (5)
Pegylated-Somatropin, 10mcg/kg
EXPERIMENTALPegylated-Somatropin, 30mcg/kg
EXPERIMENTALPegylated-Somatropin, 60mcg/kg
EXPERIMENTALPegylated-Somatropin, 120mcg/kg
EXPERIMENTALPegylated-Somatropin, 200mcg/kg
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- Age(yr)between 18 and 45
- Body mass index(BMI)between 20 and 28
- sign informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Study Officials
- PRINCIPAL INVESTIGATOR
Hu Pei, Ph.D
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2011
First Posted
April 20, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 4, 2013
Record last verified: 2010-12