Safety, Tolerability, and Pharmacokinetics of 6-Diazo-5-Oxo- <scp>L-</scp> Norleucine in Malawian Adults With and Without Malaria: A Phase 1 Dose-Escalation Clinical Trial
DON was well tolerated in healthy adults and adults with uncomplicated malaria. Higher doses were associated with transient gastrointestinal AEs. Pharmacokinetics were minimally influenced by malaria disease. These results provide critical data to guide dosing strategies for adjunctive DON in children with CM.ClinicalTrials.gov: NCT05478720.
Authors
- Osward M. Nyirenda
- Matthew B. Laurens (ORCID: https://orcid.org/0000-0003-3874-581X)
- Nicole O’Brien
- Douglas G. Postels (ORCID: https://orcid.org/0000-0001-5815-0691)
- Kingsley Zuze
- Jesse Alt (ORCID: https://orcid.org/0000-0001-5440-7891)
- Rhoda Masonga
- Brittany A. Riggle (ORCID: https://orcid.org/0000-0002-8297-8971)
- Rana Rais (ORCID: https://orcid.org/0000-0003-4059-2453)
- Athanasios Chamzas
- Neshen Moodley
- Barbara Slusher
- Susan K Pierce
- Cynthia Manyozo
- Louis H Miller
- Nginache Nampota-Nkomba
- Mathangi Gopalakrishnan
- Alice M Liomba
- Jane E Mallewa
Institutions
- University of Maryland, Baltimore (US)
- George Washington University Hospital (US)
- Nationwide Children's Hospital (US)
- Children's National (US)
- Johns Hopkins University (US)
- Johns Hopkins Medicine (US)
- Kamuzu Central Hospital (MW)
- Blantyre Institute for Community Ophthalmology (MW)
- National Institute of Allergy and Infectious Diseases (US)
Publication Details
- Journal
- The Journal of Infectious Diseases
- Published
- 2026-02-24
- DOI
- https://doi.org/10.1093/infdis/jiag121
- Primary Topic
- Malaria Research and Control
- Type
- article
- Field-Weighted Citation Impact
- 0.00