Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT03083990
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .

Key Dates

First listed
Mar 20, 2017
Start date
Mar 9, 2017
Status verified
Nov 2020
Primary completion
Aug 17, 2017
Completion
Aug 17, 2017

Study Design

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

Arms

  • Experimental: Group A
    IBI 305 ,3mg/kg, infusion in 90 minutes
  • Active Comparator: Group B
    Bevacizumab (Avastin) 3mg/kg, infusion in 90 minutes

Primary Outcome Measure

AUC0 - t [ Time Frame: 60 min before intravenous infusion, 5 min after iv. infusion, 4 hr, 12 hr, 2 days, 3 days, 5 days, 8 days, 15 days, 22 days, 29 days, 43 days, 57 days, 64 days, 71 days, 85 days ]

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