The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers. Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 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 QL1101 or EU-Avastin® in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers. Subjects would receive a single 100mg(4ml) of QL1101or EU-Avastin® injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
AUC0-∞
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers
Time frame: 99 day
Cmax
To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single
Time frame: 99 day
AUC0-t
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
Tmax
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
t1/2
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
CL
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
Vd
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
(AUC0--∞ -AUC0-t)/(AUC0--∞×100%)
To evaluate pharmacokinetic similarity between QL1101 and Avastin®
Time frame: 99 day
the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0
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;
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 99 day
immunogenicity
Immunogenicity will be assessed by the incidence of ADA and Nab.
Time frame: 99 day