NCT03030430

Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.

Detailed description

This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects. A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required. Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments. There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation. After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.

Conditions

• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	BAT1706 injection	1mg/kg, IV on day 1
BIOLOGICAL	EU-sourced Avastin	1mg/kg, IV on day 1
BIOLOGICAL	US-sourced Avastin	1mg/kg, IV on day 1

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-05-16
• Completion: 2017-06-28
• First posted: 2017-01-25
• Last updated: 2018-07-30

Locations

1 site across 1 country: New Zealand