The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
A single subcutaneous injection of PEG-rhGH with new preparation
A single subcutaneous injection of PEG-rhGH with present preparation
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192hours post-administration
Safety and tolerability (Number of participants with treatment-related adverse events)
Time frame: up to approximately 30 days
Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation
Time frame: 0 hours -192 hours post-administration
Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation
Time frame: 0 hours -192 hours post-administration
Anti-drug antibody (Number of Participants with positive ADA)
Time frame: 0 hours -192 hours post-administration
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