Malaria,FalciparumPhase 1NCT05507970
First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367
A Phase 1 study testing MMV367, MMV367 (Fed 440mg) and MMV367 (Fasted 440mg) in people with Malaria,Falciparum, run by Medicines for Malaria Venture at 1 site in United Kingdom.
Trial summary
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- MMV367, MMV367 (Fed 440mg) and MMV367 (Fasted 440mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2022to 25 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study Demographics and Contraception
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements defined in Section 9.4 Baseline characteristics
- Healthy males or non-pregnant, non-lactating healthy females.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg at screening
Who cannot join
- Medical/Surgical History and Mental Health
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Blood pressure (supine) at screening or admission outside the range of 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
- A decrease of SBP (systolic blood Pressure) ≥20 mmHg after 3 min standing and/or a decrease of DBP (diastolic blood Pressure)
Show all 33Show fewer
- ≥10 mmHg after 3 min standing, at screening
- History or presence of known structural cardiac abnormalities, family history of long QT (measured from the beginning of the QRS complex to the end of the T-wave) syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise related clinically significant cardiac events. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QT interval changes
- Presence of sinus node dysfunction, clinically significant PR interval prolongation (>210 msec), intermittent second- or third-degree atrioventricular block, complete bundle branch block, sustained cardiac arrhythmias including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles, abnormal T wave morphology which may impact on the QT/QTc assessment, or QTcF >450 msec. Participants with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the sponsor's medical monitor and the investigator
- Participants with a history of cholecystectomy or gall stones
- Participants with conditions that affect their ability to smell or taste (Part 1 only) including, but not limited to mouth ulcers, gum disease, nasal surgery and smell and/or taste disorders (e.g. dysosmia, dysgeusia, respiratory and/or sinus infection or cold) Physical Examination
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening Diagnostic assessments
- Evidence of current SARS-CoV-2 infection (severe acute respiratory syndrome)
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1 of protocol). Participants with Gilbert's Syndrome are not allowed.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission) Prior Study Participation
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- Participants who have previously been administered IMP in this study. Participants who have taken part in Part 1 are not permitted to take part in Parts 2 and 3 and participants who have taken part in Part 2 are not permitted to take part in Part 3
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood Prior and Concomitant Medication
- Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, hormonal contraception or HRT) in the 14 days before first IMP administration (see Section 11.4)
- Participants who have received a COVID-19 vaccine within 7 days before first IMP administration Lifestyle Characteristics
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
- Participant with a vegan or vegetarian diet (Part 2 only) Other
- Male participants with pregnant or lactating partners
- A score of 20 or more on the Beck Depression Inventory (BDI-II), and/or a response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) [7].
- Note, individuals with a BDI-II score of 17-19 may be enrolled, at the discretion of the investigator, if they do not have a medical history of psychiatric conditions and their mental state is not considered to pose additional risk to the health of the individual or to the execution of the trial and interpretation of the data
- Participants who are, or are immediate family members of, a study site or sponsor employee
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Single-Centre, Single Ascending Dose, Multiple Dose and Pilot Food Effect Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 in Healthy Participants
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.
In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.
Read more
In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.
In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.
Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.
Read the detailed description
Part 1 will be a double-blinded, randomised, placebo-controlled, single ascending dose (SAD) study, which will comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E will be optional), with 8 participants in each cohort. Participants will be randomly assigned to receive a single oral dose of either active IMP (investigational medicinal product) (6 participants) or placebo (2 participants) to assess its safety, tolerability and PK (pharmacokinetic) profile. Each participant will take part in one cohort. Cohort A dose is 100mg. Doses for cohorts B to E will be determined following a blinded interim review of the safety, tolerability and PK data after each cohort, prior to the dose decision for subsequent cohorts.
Part 2 will be an open-label, randomised, balanced two-period crossover, food effect evaluation. It is planned to enrol 8 participants. In Period 1, participants will be randomised to 1 of 2 treatment sequences. If a participant is randomised to receive MMV367 in the fasted state in Period 1, they will receive MMV367 in the fed state in Period 2 and vice versa. The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of MMV367 and a safe exposure window has been established in Part 1.
Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A total of 8 participants per cohort (A-C) will receive once-daily doses of MMV367 (6 participants) or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability and PK profile of multiple dosing. Cohorts 3B and 3C are optional and may proceed after a review of the safety and PK data. The dose(s) administered in Part 3 will be determined after review of the data from Part 1.
Parts 1 and 3 will follow a sentinel dosing design. For each of the three parts, participants will be screened within 28 days prior to first admission to the clinical unit on the morning of Day -1.
Part 1: In each cohort, participants will be dosed on Day 1 and will remain resident in the clinical unit until discharge on Day 5. They will attend the clinical unit for a return visit on Day 7 and again on Day 15 for end of study assessments.
Part 2: Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and will remain resident in the clinical unit until discharge on Day 12. They will attend the clinical unit on Day 14 for end of study assessments. Based on emerging PK data from Part 1, the washout period between the Period 1 and Period 2 doses may be extended.
Part 3: Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on Day 9 and again on Day 17 for end of study assessments.
For all parts, blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study.
- Conditions
- Malaria,Falciparum
- Being tested
- MMV367, Placebo, MMV367 (Fed 440mg), MMV367 (Fasted 440mg)
- Keywords
- Malaria, Healthy Volunteers
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMV367Drug
Single dose dispersed in sterile water, fasted.
PlaceboDrug
Single Dose dispersed in sterile water, fasted.
MMV367 (Fed 440mg)Drug
Also called Food Effect
Single dose dispersed in sterile water with a high fat meal.
MMV367Drug
Also called Multiple dose
Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.
PlaceboDrug
Also called Multiple dose
Single dose dispersed in sterile water, fasted, administered for 3 consecutive days.
MMV367 (Fasted 440mg)Drug
Also called Fasted
Single dose dispersed in sterile water fasted.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Single Ascending Dose Cohort A | Experimental | 100 mg MMV367, oral solution, fasted, Receives: Drug: MMV367 |
| Part 1 Single Ascending Dose Cohort B | Experimental | Single ascending dose to be determined after SAC (Safety Advisory Committee) review of previous cohort.
Intervention: MMV367, oral solution, fasted Receives: Drug: MMV367 |
| Part 1 Single Ascending Dose Cohort C | Experimental | Single ascending dose to be determined after SAC review of previous cohort.
Intervention: MMV367, oral solution, fasted Receives: Drug: MMV367 |
| Part 1 Single Ascending Dose Cohort D | Experimental | Single ascending dose to be determined after SAC review of previous cohort.
Intervention: MMV367, oral solution, fasted Receives: Drug: MMV367 |
| Part 1 Single Ascending Dose Cohort Placebo | Placebo comparator | Single ascending dose to be determined after SAC review of previous cohort.
Intervention: placebo, oral solution, fasted Receives: Drug: Placebo |
| Part 2 Food Effect Fed 440mg | Experimental | Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1.
MMV367: Single dose dispersed in sterile water. Receives: Drug: MMV367 (Fed 440mg) |
| Part 3 Multiple Dose Cohort A | Experimental | Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: MMV367 oral solution, fasted. Once daily for 3 days. Receives: Drug: MMV367 |
| Part 3 Multiple Dose Cohort A Placebo | Placebo comparator | Double-blinded, randomised, placebo-controlled, multiple-dose study.
Intervention: placebo, oral solution, fasted. Once daily for 3 days Receives: Drug: Placebo |
| Part 2 Food Effect Fasted 440mg | Experimental | Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1. Receives: Drug: MMV367 (Fasted 440mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent AEs (TEAEs): AEs that commence during/after the first dose of IMP or commence before first dose of IMP (i.e., a pre-dose AE or existing medical condition) but worsen in intensity during exposure to IMP.
Measured: Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.
Number of Clinically Significant Physical Examination Findings
In the targeted (symptom driven) physical examination, a physician will assess the participant; if the participant reports feeling unwell or has ongoing AEs, then the physician will examine the appropriate body system(s) if required.
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Changes From Baseline for Electrocardiograms (ECGs): RR Interval (The R-R Interval is the Distance Between Two Consecutive R Waves.)
Clinically important changes in mean values from baseline (individual: Day 1, Pre-dose; mean: Day 1, mean of 3 pre-dose measurements) to any post-dose time point
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Shifts from within the reference range at baseline to outside the reference range after dosing with IMP.
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes From Baseline for Respiratory Rate
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2,and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes in Heart Rate, Supine
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes in Heart Rate, Orthostatic
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Measured: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Measured: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Number of Participants with Out of Range QTcF Values
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
Number of Participants with Out of Range QTcB Values
Measured: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Clinically Important Changes From Baseline for Blood Pressure in mmHg: Supine
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Measured: Screening/day -28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in Part 3). Up to a maximum of 6.5 weeks in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start29 Jul 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malaria,FalciparumStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Quotient Sciences, Swiss BioQuant, Banook Group, The Doctors Laboratory Ltd, GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507970
- Sponsor's protocol ID
- MMV_MMV367_21_01
- Other IDs
- 2022-000918-33, ISRCTN17423851, 1005344
- Status last verified
- Dec 2024
- First submitted
- 16 Aug 2022
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Single-Centre, Single Ascending Dose, Multiple Dose and Pilot Food Effect Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05507970
- Acronym / sponsor ID
- MMV_MMV367_21_01
- Conditions
- Malaria,Falciparum
- Keywords
- Malaria, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Quotient Sciences, Swiss BioQuant, Banook Group, The Doctors Laboratory Ltd, GlaxoSmithKline
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.
In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.
In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.
In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.
Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.
Detailed description
Part 1 will be a double-blinded, randomised, placebo-controlled, single ascending dose (SAD) study, which will comprise up to 5 fasted cohorts (Cohorts 1A to 1E; Cohort 1E will be optional), with 8 participants in each cohort. Participants will be randomly assigned to receive a single oral dose of either active IMP (investigational medicinal product) (6 participants) or placebo (2 participants) to assess its safety, tolerability and PK (pharmacokinetic) profile. Each participant will take part in one cohort. Cohort A dose is 100mg. Doses for cohorts B to E will be determined following a blinded interim review of the safety, tolerability and PK data after each cohort, prior to the dose decision for subsequent cohorts.
Part 2 will be an open-label, randomised, balanced two-period crossover, food effect evaluation. It is planned to enrol 8 participants. In Period 1, participants will be randomised to 1 of 2 treatment sequences. If a participant is randomised to receive MMV367 in the fasted state in Period 1, they will receive MMV367 in the fed state in Period 2 and vice versa. The dose administered in Part 2 will be determined once predicted human therapeutic concentrations of MMV367 and a safe exposure window has been established in Part 1.
Part 3 will be a double-blinded, randomised, placebo-controlled, multiple-dose study. A total of 8 participants per cohort (A-C) will receive once-daily doses of MMV367 (6 participants) or placebo (2 participants) for 3 days, in the fasted state, to assess safety, tolerability and PK profile of multiple dosing. Cohorts 3B and 3C are optional and may proceed after a review of the safety and PK data. The dose(s) administered in Part 3 will be determined after review of the data from Part 1.
Parts 1 and 3 will follow a sentinel dosing design. For each of the three parts, participants will be screened within 28 days prior to first admission to the clinical unit on the morning of Day -1.
Part 1: In each cohort, participants will be dosed on Day 1 and will remain resident in the clinical unit until discharge on Day 5. They will attend the clinical unit for a return visit on Day 7 and again on Day 15 for end of study assessments.
Part 2: Participants will be dosed on Day 1 (Period 1 dose) and on Day 8 (Period 2 dose) and will remain resident in the clinical unit until discharge on Day 12. They will attend the clinical unit on Day 14 for end of study assessments. Based on emerging PK data from Part 1, the washout period between the Period 1 and Period 2 doses may be extended.
Part 3: Participants will receive a single dose on Days 1, 2 and 3 and will remain resident in the clinical unit until discharge on Day 7. They will attend the clinical unit for a return visit on Day 9 and again on Day 17 for end of study assessments.
For all parts, blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose Cohort A | Experimental | Drug: MMV367100 mg MMV367, oral solution, fasted, |
| Part 1 Single Ascending Dose Cohort B | Experimental | Drug: MMV367Single ascending dose to be determined after SAC (Safety Advisory Committee) review of previous cohort. Intervention: MMV367, oral solution, fasted |
| Part 1 Single Ascending Dose Cohort C | Experimental | Drug: MMV367Single ascending dose to be determined after SAC review of previous cohort. Intervention: MMV367, oral solution, fasted |
| Part 1 Single Ascending Dose Cohort D | Experimental | Drug: MMV367Single ascending dose to be determined after SAC review of previous cohort. Intervention: MMV367, oral solution, fasted |
| Part 1 Single Ascending Dose Cohort Placebo | Placebo comparator | Drug: PlaceboSingle ascending dose to be determined after SAC review of previous cohort. Intervention: placebo, oral solution, fasted |
| Part 2 Food Effect Fed 440mg | Experimental | Drug: MMV367 (Fed 440mg)Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1. MMV367: Single dose dispersed in sterile water. |
| Part 3 Multiple Dose Cohort A | Experimental | Drug: MMV367Double-blinded, randomised, placebo-controlled, multiple-dose study. Intervention: MMV367 oral solution, fasted. Once daily for 3 days. |
| Part 3 Multiple Dose Cohort A Placebo | Placebo comparator | Drug: PlaceboDouble-blinded, randomised, placebo-controlled, multiple-dose study. Intervention: placebo, oral solution, fasted. Once daily for 3 days |
| Part 2 Food Effect Fasted 440mg | Experimental | Drug: MMV367 (Fasted 440mg)Open label, 2-period cross-over, randomized, food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV367 determined to be safe in Part 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study Demographics and Contraception
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements defined in Section 9.4 Baseline characteristics
- Healthy males or non-pregnant, non-lactating healthy females.
Key exclusion criteria (33 listed)
- Medical/Surgical History and Mental Health
- ≥10 mmHg after 3 min standing, at screening
- Note, individuals with a BDI-II score of 17-19 may be enrolled, at the discretion of the investigator, if they do not have a medical history of psychiatric conditions and their mental state is not considered to pose additional risk to the health of the individual or to the execution of the trial and interpretation of the data
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 |
|---|---|---|
| MMV367Single dose dispersed in sterile water, fasted. | Drug | Part 1 Single Ascending Dose Cohort A, Part 1 Single Ascending Dose Cohort B, Part 1 Single Ascending Dose Cohort C, Part 1 Single Ascending Dose Cohort D |
| PlaceboSingle Dose dispersed in sterile water, fasted. | Drug | Part 1 Single Ascending Dose Cohort Placebo |
| MMV367 (Fed 440mg)Also: Food EffectSingle dose dispersed in sterile water with a high fat meal. | Drug | Part 2 Food Effect Fed 440mg |
| MMV367Also: Multiple doseSingle dose dispersed in sterile water, fasted, administered for 3 consecutive days. | Drug | Part 3 Multiple Dose Cohort A |
| PlaceboAlso: Multiple doseSingle dose dispersed in sterile water, fasted, administered for 3 consecutive days. | Drug | Part 3 Multiple Dose Cohort A Placebo |
| MMV367 (Fasted 440mg)Also: FastedSingle dose dispersed in sterile water fasted. | Drug | Part 2 Food Effect Fasted 440mg |
Primary outcome
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.
Treatment-emergent AEs (TEAEs): AEs that commence during/after the first dose of IMP or commence before first dose of IMP (i.e., a pre-dose AE or existing medical condition) but worsen in intensity during exposure to IMP.
Number of Clinically Significant Physical Examination Findings
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
In the targeted (symptom driven) physical examination, a physician will assess the participant; if the participant reports feeling unwell or has ongoing AEs, then the physician will examine the appropriate body system(s) if required.
Number of Changes From Baseline for Electrocardiograms (ECGs): RR Interval (The R-R Interval is the Distance Between Two Consecutive R Waves.)
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Clinically important changes in mean values from baseline (individual: Day 1, Pre-dose; mean: Day 1, mean of 3 pre-dose measurements) to any post-dose time point
Number of Participants With Changes From Baseline for Laboratory Safety Tests (Haematology, Biochemistry)
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Shifts from within the reference range at baseline to outside the reference range after dosing with IMP.
Number of Clinically Important Changes From Baseline for Respiratory Rate
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2,and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Number of Clinically Important Changes in Heart Rate, Supine
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Number of Clinically Important Changes in Heart Rate, Orthostatic
Time frame: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Number of Clinically Important Changes From Baseline for Blood Bressure in mmHg: Orthostatic
Time frame: Screening/day-28 to Day 7 in Part 1, Day 15 in Part 2, and Day 9 in Part 3, up to a maximum of 6 weeks in total
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Number of Participants With Changes From Baseline For Electrocardiograms (ECGs): QTcF (Corrected QT Interval Using the Fridericia Formula)
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants with Out of Range QTcF Values
Number of Participants With Changes From Baseline for Electrocardiograms (ECGs): QTcB (Corrected QT Interval Using the Bazett's Formula)
Time frame: Screening/day-28 to EoS visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total
Number of Participants with Out of Range QTcB Values
Number of Clinically Important Changes From Baseline for Blood Pressure in mmHg: Supine
Time frame: Screening/day -28 to EoS visit (Day 15 in Part 1, Day 14 in part 2, and Day 17 in Part 3). Up to a maximum of 6.5 weeks in total.
Clinically important changes in mean values from baseline (Day 1, Pre-dose) to any post-dose time point for any dose level of MMV367 or placebo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 MMV367, MMV367 (Fed 440mg) and MMV367 (Fasted 440mg) in people with Malaria,Falciparum, run by Medicines for Malaria Venture at 1 site in United Kingdom.
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 7 inclusion and 33 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: finished, as of the sponsor's last update on 29 Jan 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events (TEAEs) (time frame: Screening/day-28 to EoS (End of Study) visit (Day 15 in Part 1, Day 14 in part 2 and Day 17 in part 3). Up to a maximum of 6.5 weeks in total.). The study lists 11 primary outcomes in all. 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 29 Jan 2025.