Start Date
October 20, 2020
Primary Completion Date
January 20, 2021
Study Completion Date
August 18, 2021
BAT2020
After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.
Snake River Research, Idaho Falls
Lead Sponsor
Bio-Thera Solutions
INDUSTRY