Pegylated somatropin (LA growth hormone) - Novo Nordisk
(-) Safety, tolerability, pharmacokinetics and pharmacodynamics study of pegylated-somatropin in healthy volunteers (clinicaltrials.gov) - Jan 30, 2012 - P1, N=36; Recruiting; Completion date: Apr 2012 -> Nov 2012 
Completion date • Trial delayed • Growth Hormone
http://clinicaltrials.gov/ct2/show/NCT01339182
 
Jan 30, 2012
 
This study is currently recruiting participants. Verified December 2010 by Xiamen Amoytop Biotech Co., Ltd. First Received on April 14, 2011.   Last Updated on January 30, 2012   History of Changes Sponsor: Xiamen Amoytop Biotech Co., Ltd. Collaborator: Peking Union Medical College Hospital Information provided by (Responsible Party): Xiamen Amoytop Biotech Co., Ltd. ClinicalTrials.gov Identifier: NCT01339182   Purpose 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. Condition Healthy Intervention  Drug: Pegylated-Somatropin Drug: YPEG-Somatropin Phase Phase I Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label 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 Resource links provided by NLM: Drug Information available for: Somatropin Somatotropin U.S. FDA Resources  Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.: Primary Outcome Measures: 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 ] [ Designated as safety issue: Yes ] Secondary Outcome Measures: 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Estimated Enrollment: 36 Study Start Date: January 2011 Estimated Study Completion Date: November 2012 Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)