At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
TB31Fbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of Monoclonal Antibody TB31F in Healthy Malaria-naïve Adults in the Netherlands
In Brief
A Phase 1 clinical trial evaluating TB31F for Malaria,Falciparum. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria,Falciparum
CountriesNetherlands
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI)
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartFeb 2020
Primary CompletionMar 2021
TodayJul 2026
First PostedJan 23, 2020
Enrollment StartFeb 14, 2020
Primary CompletionMar 4, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.4 years ago
Interventions
TB31Fbiological
Monoclonal antibody