L9LS in Women of Childbearing Potential in Mali (NCT07060508) | Clinical Trial Compass
CompletedPhase 2
L9LS in Women of Childbearing Potential in Mali
Mali279 participantsStarted 2025-07-22
Plain-language 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
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
. Currently breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of local and systemic adverse events (AEs)
Timeframe: Days 0, 1, 3, and 7.
2
Severity of local and systemic adverse events (AEs)
Timeframe: Days 0, 1, 3, and 7.
3
Incidence of laboratory abnormalities
Timeframe: Days 7 and 14.
4
Number of participants with treatment-related laboratory adverse events
Timeframe: Days 7 and 14.
5
Pf blood-stage infection as detected by microscopic examination of thick blood smear
Timeframe: Once every 2 weeks post injection through 24 weeks.
Trial details
NCT IDNCT07060508
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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).
. Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)