drugset
drugset / Trial / NCT06413108

Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali

NCT06413108 ↗

Phase 1/2 Completed 167 enrolled Radboud University Medical Center London School of Hygiene and Tropical Medicine · collabMalaria Research and Training Center, Bamako, Mali · collab
RandomizedSequentialQuadruple-blindOther

Summary

Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat this disease. The monoclonal antibody TB31F shows promise in reducing the transmission of malaria. This clinical trial will evaluate the safety and efficacy of the monoclonal antibody TB31F.

Timeline

Start
2024-07-12
Primary completion
2026-01-16
Completion
2026-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject TB31F Monoclonal antibody 10 mg —
Subject TB31F Monoclonal antibody 30 mg —
Subject TB31F Monoclonal antibody 100 mg —
Subject TB31F Monoclonal antibody 200 mg —

Indications

Plasmodium falciparum malaria