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L9LS in Women of Childbearing Potential in Mali

NCT07060508 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-02-17

No results posted yet for this study

Summary

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali

Conditions

Interventions

BIOLOGICAL

Single dose of 1800 mg L9LS SC

A human monoclonal antibody to protect against Plasmodium falciparum.

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • University of the Sciences, Techniques and Technologies of Bamako

    collaborator OTHER

  • Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)

    collaborator UNKNOWN

  • University of Washington

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Peter Crompton, MD, MPH · National Institutes of Health (NIH)

  • Kassoum Kayentao, MD, MPH, PhD · Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT07060508 on ClinicalTrials.gov