Trials / Withdrawn
WithdrawnNCT04126044
A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS
A DOUBLE BLIND, RANDOMIZED, PARALLEL-GROUP, SINGLE-DOSE, 2-ARM, COMPARATIVE PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND BEVACIZUMAB SOURCED FROM EUROPEAN UNION ADMINISTERED TO CHINESE HEALTHY MALE VOLUNTEERS
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06439535 (CN) | This is the test drug Pfizer biosimilar of bevacizumab-EU. |
| DRUG | bevacizumab - EU | This is the reference drug bevacizumab sourced from EU |
Timeline
- Start date
- 2021-01-22
- Primary completion
- 2021-07-10
- Completion
- 2021-07-10
- First posted
- 2019-10-14
- Last updated
- 2021-04-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04126044. Inclusion in this directory is not an endorsement.