A phase I double-blind, placebo-controlled (Part B only), randomised trial to evaluate the safety, tolerability, and pharmacokinetics of single dose in fed state, and repeat doses of DNDI-6899 in healthy participants [version 1; peer review: awaiting peer review]

Дата публикации: 10-07-2026 13:56:46

Background Visceral Leishmaniasis (VL) – also known as Kala-azar – is a disease caused by obligate intracellular protozoan parasites, particularly the species Leishmania donovani and Leishmania infantum. VL causes fever, weight loss, severe haematological damage, spleen and liver enlargement, and, if left untreated, cases of VL are typically fatal. Despite the significant change in the epidemiology of the disease in recent years, VL remains a major problem in Africa but also in the Americas. The main barrier to the elimination goal refers to the difficulty in offering accessible, effective and safe treatments. While therapies are available to treat the disease, none are ideal for use in resource poor settings where the disease is endemic, due to the unfavourable safety profile of drugs, logistical complexity and cost. As such there is a real unmet medical need for new, short course oral drugs for the treatment of this disease. DNDI-6899 is a novel pyrazolopyrimidine derivative that has the potential to be effective against VL. Methods This is a first in human clinical investigation with Food Effect (Part A) and Double-Blind Multiple Ascending Dose (Part B) in healthy participants. In Part A, 12 participants will be randomised to fed or fasted conditions (treatment period 1) and dosed with DNDI-6899. The same participants will then be treated under opposite conditions (treatment period 2) after an appropriate washout period. In Part B, participants will be randomised to either DNDI-6899 or placebo in either fed or fasted conditions. Treatment conditions in Part B will depend on the results in Part A. All participants will provide written informed consent. Conclusions This trial will assess the safety, tolerability, and pharmacokinetics of single and repeat doses of DNDI-6899 in healthy participants. International Standard Randomised Control Trial Number (ISRCTN) registration: https://www.isrctn.com/ISRCTN31974125

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