Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F

Phase 1 Completed 25 enrolled Radboud University Medical Center The PATH Malaria Vaccine Initiative (MVI) · collab

Non-randomizedSequentialOpen-labelPrevention

Summary

This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults. This study will also evaluate the pharmacokinetics of TB31F and the functional activity of mAb TB31F in the standard membrane feeding assay.

Timeline

Start: 2020-02-14
Primary completion: 2021-03-04
Completion: 2021-03-04

Publications

van der Boor SC, Smit MJ, van Beek SW, Ramjith J, Teelen K, van de Vegte-Bolmer M, van Gemert GJ, Pickkers P, Wu Y, Locke E, Lee SM, Aponte J, King CR, Birkett AJ, Miura K, Ayorinde MA, Sauerwein RW, Ter Heine R, Ockenhouse CF, Bousema T, Jore MM, McCall MBB. Safety, tolerability, and Plasmodium falciparum transmission-reducing activity of monoclonal antibody TB31F: a single-centre, open-label, first-in-human, dose-escalation, phase 1 trial in healthy malaria-naive adults. Lancet Infect Dis. 2022 Nov;22(11):1596-1605. doi: 10.1016/S1473-3099(22)00428-5. Epub 2022 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TB31F	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	TB31F	Monoclonal antibody	1 mg/kg	Intravenous
Subject	TB31F	Monoclonal antibody	3 mg/kg	Intravenous
Subject	TB31F	Monoclonal antibody	10 mg/kg	Intravenous
Subject	TB31F	Monoclonal antibody	100 mg	Intravenous

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F

Summary

Timeline

Publications

Drugs

Indications