Pharmacokinetics and Safety Study of ASKB1202 in Chinese Healthy Subjects

Sponsor
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Study ID
NCT03115762
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • bevacizumab — BIOLOGICAL
    recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells
  • ASKB1202 — BIOLOGICAL

Study Details

This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of ASKB1202 compared to bevacizumab sold in China and Europe.

Key Dates

First listed
Apr 14, 2017
Start date
Jun 30, 2017
Status verified
Apr 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

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

Arms

  • Experimental: ASKB1202
    Subject to receive one intravenous (i.v.) infusion of ASKB1202
  • Active Comparator: bevacizumab A
    Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in China
  • Active Comparator: bevacizumab B
    Subject to receive one intravenous (i.v.) infusion of bevacizumab sold in Europe

Primary Outcome Measure

Cmax [ Time Frame: up to 100 days ]

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