Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects
This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects. This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups. Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
304
A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
The Second Hospital of Anhui Medical University
Anhui, Anhui, China
RECRUITINGArea under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Maximum (peak) serum drug concentration (Cmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Time to reach maximum (peak) serum drug concentration (Tmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Elimination half life (t1/2)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Total clearance (CL)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Apparent volume of distribution during terminal phase (Vz)
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A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90
Mean residence time (MRT)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to Day 90