MalariaPhase 1NCT07758985
Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.
A Phase 1 study testing Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state and Cohort 3 high dose lotilaner with a high-fat meal in people with Malaria, run by Medicines for Malaria Venture at 1 site in Mali.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state and Cohort 3 high dose lotilaner with a high-fat meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteMali
- Study dates
- 14 Sep 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female volunteers aged 18-55 years of age (inclusive) at the time of signing the Informed Consent.
- Total body weight (BW) ≥50 kg, and a body mass index (BMI) of 18-32 kg/m2 (inclusive).
- Residence within the study area.
- Judged healthy based on a comprehensive clinical assessment, including a detailed medical history and full physical examination.
- Axillary temperature <37.0ºC without history of fever during the previous week.
- Willingness to adhere to the requirement regarding the use of contraception, as per the study protocol
- Willingness and ability to adhere to study requirements and to participate and communicate for the duration of the trial.
- Agreement to provide current contact details
Who cannot join
- Evidence of clinically significant, gastrointestinal, cardiac, lung, hepatic, neurologic, psychiatric, rheumatologic, autoimmune, dermatologic, hematological, oncologic, or renal disease by anamnesis, physical examination, and/or laboratory tests.
- Known Central Nervous System disorders or a history of seizures.
- Any surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy).
- Signs and symptoms of uncomplicated or severe malaria. An asymptomatic Plasmodium infection is not exclusionary.
- Female who is lactating or pregnant according to the serum pregnancy test at Screening.
- History of significant hypersensitivity to lotilaner (including excipients of the formulations) or any related products.
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- History of a severe allergic reaction or anaphylaxis or severe hypersensitivity reactions to any drugs.
- Significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
- Participants who are current smokers or have used nicotine-containing products within 90 days prior to study treatment administration.
- Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years).
- Known asplenia or functional asplenia.
- Known history or evidence of clinically significant cardiovascular abnormalities
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results.
- Known diabetes or diabetes identified during screening
- Any serious medical condition or abnormality in clinical laboratory tests that, in the opinion of the investigator, precludes the Participant's safe participation in and completion of the study or affects the ability of the Participant to understand and comply with the study protocol.
- Prior antimalarial therapy or antibiotics with antimalarial activity (prophylaxis or treatment) within four weeks or five half-lives (whichever is longer) before study drug administration.
- Current or recent use of any prohibited medications according to the study protocol
- Pre-planned surgery during the study.
- Intake of lotilaner in the six months before the study drug administration.
- Receipt of any investigational product within the past 30 days or five half-lives (whichever is longer) before screening.
- Use of St. John's wort in the 28 days before study treatment administration and through the duration of the study.
- Participation or planned participation in an interventional trial with an investigational product before the last required protocol visit.
- Treatment with systemic ivermectin within four weeks or five half-lives (whichever is longer) before Screening.
- Any individual who, in the judgment of an Investigator, is likely to be non-compliant during the trial, or is unable to cooperate.
- Any individual who is an Investigator, research assistant, pharmacist, trial coordinator, or other staff thereof, directly involved in conducting the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peya Gaye contact
Mali1 site, 1 recruiting
- Recruiting
Malaria Research and Training Center
Bamako
Prof. Alassane Dicko, MD, PhD, +223 6674 2296, adicko@icermali.org
About this study
Official title: A Phase 1b, Single-Center, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Mosquitocidal Activity of Single Oral Doses of Lotilaner in Healthy Participants in Mali.
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.
Read the detailed description
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.
- Conditions
- Malaria
- Being tested
- Cohort 1 low dose lotilaner with a high-fat meal, Cohort 1 low dose placebo with a high-fat meal, Cohort 2 high dose lotilaner in fasted state, Cohort 2 high dose placebo in fasted state, Cohort 3 high dose lotilaner with a high-fat meal
- Keywords
- food effect, safety, pharmacokinetics, lotilaner, mosquitocidal activity
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 low dose lotilaner with a high-fat mealDrug
Participants will receive a single low dose of lotilaner with a high-fat meal
Cohort 1 low dose placebo with a high-fat mealOther
Participants will receive a single low dose of placebo with a high-fat meal
Cohort 2 high dose lotilaner in fasted stateDrug
Participants will receive high dose lotilaner in a fasted state
Cohort 2 high dose placebo in fasted stateOther
Participants will receive a single high dose of placebo in a fasted state
Cohort 3 high dose lotilaner with a high-fat mealDrug
Participants will receive a single high dose of lotilaner after a high-fat meal
Cohort 3 high dose placebo with a high-fat mealOther
Participants with receive a single high dose of placebo with a high-fat meal
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | low dose lotilaner with a high-fat meal Receives: Drug: Cohort 1 low dose lotilaner with a high-fat meal |
| Cohort 2 | Experimental | high dose lotilaner in fasted state Receives: Drug: Cohort 2 high dose lotilaner in fasted state |
| Cohort 3 | Experimental | high dose lotilaner with high-fat meal Receives: Drug: Cohort 3 high dose lotilaner with a high-fat meal |
| low dose placebo with high-fat meal | Placebo comparator | Not described Receives: Other: Cohort 1 low dose placebo with a high-fat meal |
| high dose placebo in fasted state | Placebo comparator | Not described Receives: Other: Cohort 2 high dose placebo in fasted state |
| high dose placebo with a high-fat meal | Placebo comparator | Not described Receives: Other: Cohort 3 high dose placebo with a high-fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Lotilaner
All-cause mortality, Serious Adverse Events, Other (not including Serious) Adverse Events (frequency threshold:5%)
Measured: From hour 0 on Day 1 through the end of the study (Day 169)
Secondary outcomes (7)
Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood
Mosquitocidal activity of Lotilaner against Anopheles gambiae mosquitoes (single blood feeding timepoint)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start14 Sep 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, London School of Hygiene and Tropical Medicine, Malaria Research and Training Center, Bamako, Mali
- Responsible party
- Sponsor
- Investigators
- Prof. Alassane Dicko, MD, PhD, Principal investigator, MRTC, Université des Sciences Techniques et Technologies de Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758985
- Sponsor's protocol ID
- MMV_Loti_23_01
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Single-Center, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Mosquitocidal Activity of Single Oral Doses of Lotilaner in Healthy Participants in Mali.
- ClinicalTrials.gov ID
- NCT07758985
- Acronym / sponsor ID
- MMV_Loti_23_01
- Conditions
- Malaria
- Keywords
- food effect, safety, pharmacokinetics, lotilaner, mosquitocidal activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, London School of Hygiene and Tropical Medicine, Malaria Research and Training Center, Bamako, Mali
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Cohort 1 low dose lotilaner with a high-fat meallow dose lotilaner with a high-fat meal |
| Cohort 2 | Experimental | Drug: Cohort 2 high dose lotilaner in fasted statehigh dose lotilaner in fasted state |
| Cohort 3 | Experimental | Drug: Cohort 3 high dose lotilaner with a high-fat mealhigh dose lotilaner with high-fat meal |
| low dose placebo with high-fat meal | Placebo comparator | Other: Cohort 1 low dose placebo with a high-fat meal |
| high dose placebo in fasted state | Placebo comparator | Other: Cohort 2 high dose placebo in fasted state |
| high dose placebo with a high-fat meal | Placebo comparator | Other: Cohort 3 high dose placebo with a high-fat meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female volunteers aged 18-55 years of age (inclusive) at the time of signing the Informed Consent.
- Total body weight (BW) ≥50 kg, and a body mass index (BMI) of 18-32 kg/m2 (inclusive).
- Residence within the study area.
- Judged healthy based on a comprehensive clinical assessment, including a detailed medical history and full physical examination.
- Axillary temperature <37.0ºC without history of fever during the previous week.
Key exclusion criteria (25 listed)
- Evidence of clinically significant, gastrointestinal, cardiac, lung, hepatic, neurologic, psychiatric, rheumatologic, autoimmune, dermatologic, hematological, oncologic, or renal disease by anamnesis, physical examination, and/or laboratory tests.
- Known Central Nervous System disorders or a history of seizures.
- Any surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy).
- Signs and symptoms of uncomplicated or severe malaria. An asymptomatic Plasmodium infection is not exclusionary.
- Female who is lactating or pregnant according to the serum pregnancy test at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 low dose lotilaner with a high-fat mealParticipants will receive a single low dose of lotilaner with a high-fat meal | Drug | Cohort 1 |
| Cohort 1 low dose placebo with a high-fat mealParticipants will receive a single low dose of placebo with a high-fat meal | Other | low dose placebo with high-fat meal |
| Cohort 2 high dose lotilaner in fasted stateParticipants will receive high dose lotilaner in a fasted state | Drug | Cohort 2 |
| Cohort 2 high dose placebo in fasted stateParticipants will receive a single high dose of placebo in a fasted state | Other | high dose placebo in fasted state |
| Cohort 3 high dose lotilaner with a high-fat mealParticipants will receive a single high dose of lotilaner after a high-fat meal | Drug | Cohort 3 |
| Cohort 3 high dose placebo with a high-fat mealParticipants with receive a single high dose of placebo with a high-fat meal | Other | high dose placebo with a high-fat meal |
Primary outcome
Safety and tolerability of Lotilaner
Time frame: From hour 0 on Day 1 through the end of the study (Day 169)
All-cause mortality, Serious Adverse Events, Other (not including Serious) Adverse Events (frequency threshold:5%)
7 secondary outcomes
Anopheles gambiae mosquito survivorship (% alive) following membrane feeding on participant blood
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
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
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
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
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
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
Time frame: At protocol-specified timepoints through the end of pharmacokinetic sampling, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peya Gaye contact
Prof. Alassane Dicko, MD, PhD principal investigator
MRTC, Université des Sciences Techniques et Technologies de Bamako, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state and Cohort 3 high dose lotilaner with a high-fat meal in people with Malaria, run by Medicines for Malaria Venture at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Demarest (+41225550300, info@mmv.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Lotilaner (time frame: From hour 0 on Day 1 through the end of the study (Day 169)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.