A Phase I Clinical Trial of Bevacizumab Injection

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT05476341
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.

Key Dates

First listed
Jul 27, 2022
Start date
Apr 6, 2017
Status verified
Jul 2022
Primary completion
Aug 18, 2017
Completion
Aug 18, 2017

Study Design

Enrollment
98 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab injection
    On the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes).
  • Active Comparator: Bevacizumab injection（Avastin）
    On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes).

Primary Outcome Measure

Plasma concentration-area under time curve（AUC0-t） [ Time Frame: Within 30 minutes before administration to 1680 hours (day 71) ]

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