NCT06413108

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

A Phase 1/2a Single Centre, Randomised, Placebo-controlled, Double-blind, Dose-escalation, Age De-escalation, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Malaria-exposed Malian Adults and Children

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
DRUG	TB31F	transmission-blocking monoclonal antibody TB31F
OTHER	Normal saline	normal saline as control (placebo)

Timeline

• Start date: 2024-07-12
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2024-05-14
• Last updated: 2026-01-22

Locations

1 site across 1 country: Mali