A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS

Sponsor
Pfizer
Study ID
NCT04126044
Phase
PHASE1
Status
Withdrawn

Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
MALE
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • PF-06439535 (CN) — DRUG
    This is the test drug Pfizer biosimilar of bevacizumab-EU.
  • bevacizumab - EU — DRUG
    This is the reference drug bevacizumab sourced from EU

Study Details

This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. Approximately 66 subjects will be enrolled to ensure that at least 58 subjects (29 per arm) complete the study procedures and have evaluable PK data. The study will be conducted at 1 center in China.

Key Dates

First listed
Oct 14, 2019
Start date
Jan 22, 2021
Status verified
Apr 2021
Primary completion
Jul 10, 2021
Completion
Jul 10, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Reference: bevacizumab - EU
  • Experimental: Test: PF-06439535 (CN)

Primary Outcome Measure

AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration) [ Time Frame: From Day 1 to Day 71 ]

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