DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study: Part 1-Adult Arm
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The initial study to be conducted under this IND is a 2-arm dose escalation study. The two
arms will be open-label, dose escalation, and will define the safety of
6-diazo-5-oxo-L-norleucine (DON) in African adults (>18 years old), who are healthy or who
have uncomplicated malaria.
Each of the two adult arms will enroll 40 participants broken down into 4 dosage groups with
safety evaluations before each dose increase. The first 10 participants enrolled will receive
0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, the dose will be increased to
1.0 mg/kg IV DON, and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg
IV DON. Each adult dosage group contains 10 healthy participants and 10 participants with
uncomplicated malaria. The total number of adult participants enrolled is 80 (20 participants
at 4 doses). All participants will receive only one dose of DON.
Adult participants will receive a premedication dose of the antiemetic ondansetron, 8 mg IV,
administered 30 minutes prior to DON, and repeated once 6 hours later. The duration of study
participation for all adult participants is six months.
Once the safety profile in adults is completed, a second protocol is planned in children with
Cerebral Malaria.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Douglas Postels, MD, MS
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)