9
Participants
Start Date
September 25, 2019
Primary Completion Date
January 11, 2021
Study Completion Date
January 11, 2021
AXA4010
The study will initiate with approximately eight (8) adult subjects (≥18 y/o) with SCD (Cohort 1). Each subject will receive AXA4010 twice a day (BID) for 12 weeks. Safety and tolerability will be monitored, and study procedures will be performed. Analysis of safety, tolerability and laboratory assessments at week 12 would be performed. Based on the 12-week observations from at least three subjects in Cohort 1, subsequent Cohorts 2 and 3 in Part II may be initiated.
Primary Care research, Atlanta
Foundation for Sickle Cell Disease Research, Hollywood
Advanced Pharma CR, LLC, Miami
Newark Beth Israel Medical Center, Newark
Lead Sponsor
Axcella Health, Inc
INDUSTRY