Safety, tolerability and pharmacokinetics of DNDI‐6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants
After a single administration of up to 380 mg by oral route, DNDI-6148 had an acceptable safety and tolerability profile and a favourable PK profile. These data support further clinical development.
Authors
- Mathilde Latreille‐Barbier
- Richard M. Hoglund (ORCID: https://orcid.org/0000-0002-5322-912X)
- Frauke Assmus (ORCID: https://orcid.org/0000-0002-1146-3452)
- Jean‐Yves Gillon (ORCID: https://orcid.org/0000-0003-1467-0403)
- Sabrina Loyau
- Yves Donazzolo (ORCID: https://orcid.org/0009-0002-4314-607X)
- Séverine Blesson (ORCID: https://orcid.org/0000-0002-3007-8015)
- Sophie Delhomme
- Stéphanie Braillard (ORCID: https://orcid.org/0000-0002-6354-3059)
- Byron Arana (ORCID: https://orcid.org/0000-0002-8407-7093)
- Joel Tärning (ORCID: https://orcid.org/0000-0003-4566-4030)
- Delphine Launay (ORCID: https://orcid.org/0000-0001-6862-4723)
- Pegah Maghdooni
Institutions
- European Organisation for Rare Diseases (FR)
- Drugs for Neglected Diseases Initiative (CH)
- Victor (Japan) (JP)
- Mahidol Oxford Tropical Medicine Research Unit (TH)
- SGS (Belgium) (BE)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2025-11-20
- DOI
- https://doi.org/10.1002/bcp.70328
- Primary Topic
- Research on Leishmaniasis Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Bill and Melinda Gates Foundation
- World Health Organization
- Bundesministerium für Bildung und Forschung
- Ministerie van Buitenlandse Zaken
- Drugs for Neglected Diseases initiative