The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers. Participants will receive a single injection of QL2107/ Keytruda® (China)/Keytruda® (US).Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.
This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL2107 or Keytruda® (China/US) in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2107 or Keytruda® (China/US) in healthy volunteers. Subjects would receive a single 100mg(4ml) of QL2107or Keytruda® (China/US)injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGAUC0-∞
To evaluate pharmacokinetic similarity between QL2107 and Keytruda® (china/US)after a single intravenous infusion in healthy volunteers
Time frame: 113day
safety and immunogenicity
Safety, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.after a single intravenous infusion in healthy volunteers;Immunogenicity will be assessed by the incidence of ADA and Nab.
Time frame: 113day
Cmax
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
Tmax
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
AUC0-t
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
t1/2
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
CL
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
Vd
To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day
AUC_%Extrap
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To evaluate pharmacokinetic similarity between QL2107 and Keytruda®
Time frame: 113day