This first-in-human phase 1 trial evaluated three dosing regimens of intranasal artesunate powder in adult volunteers, focusing on safety, tolerability and systemic pharmacokinetics as a possible pre-referral approach for severe malaria.
Key findings
- No severe adverse events were observed, and shortly post-dose events were mild. Artesunate was rapidly absorbed, but inter-individual variability was high and dose-normalised dihydroartemisinin exposure suggested a nonlinear dose–exposure relationship.
Why this matters globally
If later trials establish dosing, safety and efficacy in patients, especially children, intranasal delivery could simplify pre-referral treatment where injectable therapy is delayed. This phase 1 study does not change current treatment practice.
Thai researcher contribution
Joel Tarning is affiliated with Mahidol University and the Mahidol Oxford Tropical Medicine Research Unit, reflecting Thai-network expertise in malaria pharmacokinetics.
Limitations to consider
This is a small phase 1 study in healthy adults; sample size and dose details require full-text review. It did not test malaria patients, children, emergency use or clinical outcomes. High variability and nonlinearity require further dose work, and rare harms cannot be excluded.