L9LS in Women of Childbearing Potential in Mali

NCT07060508 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: L9LS in WOCBP
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

Brief 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

Malaria

Outcome Measures

Primary Outcomes (5)

• Incidence of local and systemic adverse events (AEs)

  Occurring within 7 days after the administration of study agent

  Days 0, 1, 3, and 7.

• Severity of local and systemic adverse events (AEs)

  Occurring within 7 days after the administration of study agent

  Days 0, 1, 3, and 7.

• Incidence of laboratory abnormalities

  Occurring within 14 days after the administration of study agent

  Days 7 and 14.

• Number of participants with treatment-related laboratory adverse events

  Occurring within 14 days after the administration of study agent

  Days 7 and 14.

• Pf blood-stage infection as detected by microscopic examination of thick blood smear

  Once every 2 weeks post injection through 24 weeks.

Secondary Outcomes (2)

• Pf blood-stage infection as detected by thick blood smear and RT-PCR

  Blood smear once every 2 weeks post injection through 24 weeks.

• Concentration of L9LS in sera of recipients.

  Through 24 weeks.

Study Arms (3)

L9LS in healthy Malian WOCBP

EXPERIMENTAL

Biological: Single dose of 1800 mg L9LS SC

Placebo in healthy Malian WOCBP

PLACEBO COMPARATOR

Other: Placebo

L9LS in healthy Malian adult males

EXPERIMENTAL

Biological: Single dose of 1800 mg L9LS SC

Interventions

Single dose of 1800 mg L9LS SC BIOLOGICAL

A human monoclonal antibody to protect against Plasmodium falciparum.

L9LS in healthy Malian WOCBP; L9LS in healthy Malian adult males

Placebo OTHER

Normal saline

Placebo in healthy Malian WOCBP

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
• Males aged ≥18 and ≤49 years (no weight restrictions).
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• In good general health and without clinically significant medical history.
• Able to provide informed consent.
• Willing to have blood samples and data stored for future research.
• Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.
• Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study Day 0 through the final study visit as described below.
• Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device.

You may not qualify if:

• Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
• Currently breastfeeding.
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.
• Study comprehension examination score of \<80% correct or per investigator discretion.
• Hemoglobin, WBC, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
• Clinically significant abnormal electrocardiogram (ECG; QTc \>460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• Receipt of any investigational product within the past 30 days.
• Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• History of a severe allergic reaction or anaphylaxis.
• Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).
• Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
• Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institutes of Health (NIH): collaborator
• Malaria Research and Training Center, Bamako, Mali: collaborator
• Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS): collaborator
• University of Washington: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Indiana University School of Medicine: collaborator
• University of the Sciences, Techniques and Technologies of Bamako: collaborator

Study Sites (3)

Faladje MRTC Clinic

Faladié, Koulikoro, Mali

RECRUITING

Kalifabougou MRTC Clinic

Kalifabougou, Koulikoro, Mali

RECRUITING

Torodo MRTC Clinic

Torodo, Koulikoro, Mali

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Peter Crompton, MD, MPH

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

• Kassoum Kayentao, MD, MPH, PhD

  Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassoum Kayentao, MD, MPH, PhD

CONTACT

+223 7646 0173; kayentao@icermali.org

Boubacar Traore, PharmD, PhD

CONTACT

+223 2022 1417; bouba.traore@mrtcbko.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Trial

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 11, 2025
• Study Start: July 22, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared at the time of publication or shortly thereafter.
• Access Criteria: Data from this study may be requested from other researchers indefinitely after the completion of the primary endpoint by contacting the Laboratory of Immunogenetics at NIH

Locations

MA (3)