A Phase 1 interventional study of Cohort 1 low dose lotilaner with a high-fat meal and Cohort 1 low dose placebo with a high-fat meal in Malaria, sponsored by Medicines for Malaria Venture. Recruiting at 1 site in Mali. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Medicines for Malaria Venture · Phase 1, Interventional, and Treatment
This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy, adult participants living in Mali.
Study Design and Recruitment
There will be 3 staggered cohorts of 25 participants each ( 75 participants in total). In each cohort, participants will be randomized in a 4:1 ratio, with 20 receiving a single dose of lotilaner and 5 receiving placebo. The next cohort will commence dosing only following a favorable interim review of at least 8 days of safety and tolerability of the previous cohort(s). The IMP will be administered on the morning of Day 1, either while fasting or 30 minutes after a high-fat meal.
Participants will return to the clinical unit for follow-up visits according to the schedule of assessments for approximately 6 months.
Blood samples will be collected at regular intervals for safety assessment, PK analyses, and evaluation of mosquitocidal efficacy.
Mosquitocidal efficacy of collected blood samples from trial participants will be evaluated using mosquito membrane feeding assays.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 75 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Medicines for Malaria Venture is the lead sponsor of 66 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
low dose lotilaner with a high-fat meal
Drug: Cohort 1 low dose lotilaner with a high-fat meal
high dose lotilaner in fasted state
Drug: Cohort 2 high dose lotilaner in fasted state
high dose lotilaner with high-fat meal
Drug: Cohort 3 high dose lotilaner with a high-fat meal
Other: Cohort 1 low dose placebo with a high-fat meal
Other: Cohort 2 high dose placebo in fasted state
Other: Cohort 3 high dose placebo with a high-fat meal
Participants will receive a single low dose of lotilaner with a high-fat meal
Participants will receive a single low dose of placebo with a high-fat meal
Participants will receive high dose lotilaner in a fasted state
Participants will receive a single high dose of placebo in a fasted state
Participants will receive a single high dose of lotilaner after a high-fat meal
Participants with receive a single high dose of placebo with a high-fat meal
Safety and tolerability of Lotilaner
All-cause mortality, Serious Adverse Events, Other (not including Serious) Adverse Events (frequency threshold:5%)
Time frame: From hour 0 on Day 1 through the end of the study (Day 169)
Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood
Mosquitocidal activity of Lotilaner against Anopheles gambiae mosquitoes (single blood feeding timepoint)
Time frame: Follow up day 34 (5 days post mosquito feeding, on blood collected from participants at follow up day 29)
Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood
Mosquitocidal activity of lotilaner against Anopheles gambiae mosquitoes (multiple blood feeding timepoints)
Time frame: Follow up 1-5 days post mosquito feeding on blood collected from participants between study days 1 to 85, according to the schedule of assessments
Aedes Aegypti mosquito survivorship (% alive) following membrane feeding on participant blood
Mosquitocidal activity of Lotilaner against Aedes aegypti mosquitoes (multiple blood feeding timepoints)
Time frame: Follow up 1-5 days post mosquito feeding on blood collected from participants between study days 1 to 85, according to the schedule of assessments
Maximum observed concentration (Cmax) of Lotilaner in whole blood
Pharmacokinetics of single dose of Lotilaner in healthy adults
Time frame: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
Terminal serum half-life (t½) of Lotilaner in whole blood
Pharmacokinetics of single dose of Lotilaner in healthy adults
Time frame: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
Time to reach maximum concentration (tmax) of Lotilaner in whole blood
Pharmacokinetics of single dose of Lotilaner in healthy adults
Time frame: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
Area under the concentration-time curve (AUC) of Lotilaner in whole blood
Pharmacokinetics of single dose of Lotilaner in healthy adults
Time frame: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
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Medicines for Malaria Venture