Trial reportBritish journal of clinical pharmacology2026
Safety, tolerability and pharmacokinetics of DNDI-6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants.
Trial report in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Safety, tolerability and pharmacokinetics of DNDI-6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants.British journal of clinical pharmacology · 2026Trial
- Visceral leishmaniasis: an integrated review of resistance mechanisms, host immunometabolism, and next generation therapeutics.Inflammopharmacology · 2026Review
- Translational Pharmacokinetic-Pharmacodynamic Modeling and Efficacious Human Dose Prediction of DNDI-6148 for the Treatment of Cutaneous Leishmaniasis.Clinical and translational science · 2026Article
- Population pharmacokinetics of DNDI-6148 in healthy adults.PLoS neglected tropical diseases · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
aimThe benzoxaborole derivative DNDI-6148 is an antiparasitic agent with activity against multiple Leishmania protozoan species, including L. infantum and L. donovani, which cause visceral leishmaniasis. We investigated the safety, tolerability and pharmacokinetics of single oral doses of DNDI-6148 in a randomized, parallel-group, placebo-controlled, first-in-human study in 64 healthy participants.
methodsEight cohorts of eight participants each were enrolled. DNDI-6148, formulated as a suspension in ORA-Sweet® was administered orally as single 10-380 mg doses. Pharmacokinetics (PK) and safety were assessed for four (cohorts receiving 10-80 mg DNDI-6148) or six (cohorts receiving 160-380 mg DNDI-6148) days after dosing.
resultsSixteen adverse events (AEs) were experienced by 13 participants (20.3%), all mild or moderate in severity and resolved by the end of the study. No AE led to any participant withdrawal, and no fatal or serious AEs were reported. DNDI-6148 was relatively slowly absorbed (t
conclusionAfter 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.
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