Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
Information source: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Pegylated-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug); YPEG-Somatropin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Xiamen Amoytop Biotech Co., Ltd. Official(s) and/or principal investigator(s):
Hu Pei, Ph.D, Principal Investigator, Affiliation: Peking Union Medical College Hospital
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.
Clinical Details
Official title: A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Measurement of the IGF-1 levels for pharmacodynamics study
Secondary outcome: Measuring the drug levels in blood samplesMeasurement of IGFBP-3 levels for pharmacodynamic study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Peking Union Medical College Hospital, Beijing, Beijing 100032, China
Additional Information
Starting date: January 2011
Last updated: January 31, 2013
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