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Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F — TB31F  

Malaria,Falciparum Clinical Trial

Official title:
Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of Monoclonal Antibody TB31F in Healthy Malaria-naïve Adults in the Netherlands

Clinical Trial 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.

Clinical Trial Description

This phase 1 study aims to assess the safety and tolerability of monoclonal antibody (mAb) TB31F administered intravenously or subcutaneously in healthy, malaria naïve, adults at the Radboud University Medical Center (Radboudumc). Five groups will receive a single dose of mAb TB31F. Group 1 (n=5) will receive 0.1 mg/kg TB31F, Group 2 (n=5) will receive 1 mg/kg TB31F, group 3 (n=5) will receive 3 mg/kg TB31F, and group 4 (n=5) will receive 10 mg/kg mAb TB31F intravenously. Group 5 will receive 100mg TB31F subcutaneously. Twenty-five (n=25) subjects will be enrolled, as well as 1 reserve subject per group. Safety follow-up will be done at following times: baseline, end of infusion (EOI), 1, 3, 6 and 24 hours and 2, 7, 14, 21, 28, 56 and 84 days after administration. Extra follow-up visits at 4 and 10 days after administration for collection of serum/plasma for pharmacokinetic and pharmacodynamic measurements will be performed in group 5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04238689
Study type Interventional
Source Radboud University Medical Center
Contact
Status Completed
Phase Phase 1
Start date February 14, 2020
Completion date March 4, 2021
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