To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease

NACompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

January 11, 2021

Study Completion Date

January 11, 2021

Conditions
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell DiseaseAnemia, Sickle CellSickle Cell AnemiaSickle Cell DisordersSickle Cell Disease
Interventions
DIETARY_SUPPLEMENT

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.

Trial Locations (4)

30312

Primary Care research, Atlanta

33021

Foundation for Sickle Cell Disease Research, Hollywood

33147

Advanced Pharma CR, LLC, Miami

07112

Newark Beth Israel Medical Center, Newark

Sponsors
All Listed Sponsors
lead

Axcella Health, Inc

INDUSTRY

NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease | Biotech Hunter | Biotech Hunter