Clinical Trial in Chinese Healthy Volunteers of GB222

Sponsor
Genor Biopharma Co., Ltd.
Study ID
NCT04175158
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • GB222 — BIOLOGICAL
    Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.
  • Bevacizumab — BIOLOGICAL
    Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is \> 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.

Study Details

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Key Dates

First listed
Nov 22, 2019
Start date
Apr 24, 2017
Status verified
Nov 2019
Primary completion
Aug 31, 2020
Completion
Nov 30, 2020

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GB222
    1mg/kg
  • Active Comparator: Bevacizumab
    1mg/kg

Primary Outcome Measure

AUC 0- t [ Time Frame: Up to 84 days ]

Central Contacts

Related Studies