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Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F

NCT04238689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-03-27

Study results available
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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.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

TB31F

Monoclonal antibody

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Matthew BB McCall, MD, PhD · Radboud University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238689 on ClinicalTrials.gov