drugset / Trial / NCT04126044
A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS
RandomizedParallel-groupDouble-blindOther
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.
Timeline
- Start
- 2021-01-22
- Primary completion
- 2021-07-10
- Completion
- 2021-07-10
Outcome
Outcome not reported
Stopped (Enrollment): “The study was withdrawn prior to enrollment after a comprehensive review of the biosimilars market and the company's global manufacturing network.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | PF-06439535 | Unknown | — | Intravenous |
Indications
No indication recorded.