MalariaPhase 1NCT05205941
MMV533 Plasmodium Falciparum Volunteer Infection Study
A Phase 1 study testing MMV688533 in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.
Trial summary
A Phase 1b study to assess the safety, tolerability and antimalarial activity of MMV533 against Plasmodium falciparum 3D7 blood stage infection in healthy volunteers 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?
- MMV688533
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Mar 2022to 2 Sep 2022
- 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
- Having given written informed consent prior to undertaking any study-related procedure.
- Male or female aged between 18 to 55 years inclusive.
- Available for the duration of the study and for 2 weeks following the End of Study Visit (EOS).
- Lives with a spouse, family member, or housemate from the time of inoculation with the malaria challenge agent through to the EOS.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
- Willing to defer blood donations to a blood service for a minimum of 6 months after the EOS.
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- Heterosexual women of childbearing potential (WOCBP) must agree to the use of a highly effective method of birth control (see below) combined with a barrier contraceptive from the screening visit until 30 days after the last dose of the IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of IMP) and have a negative result on urine pregnancy test performed before inoculation with the malaria challenge agent.
- Women of non-childbearing potential (WONCBP)
- Males who have, or may have female sexual partners of child bearing potential during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or condom plus intrauterine device, or condom plus stable oral/transdermal/injectable/implantable hormonal contraceptive by the female partner, from the time of informed consent through to 60 days (covering a spermatogenesis cycle) after the last dose of the IMP. Abstinent males must agree to start a double method if they begin sexual relationship with a female during the study and up to 60 days after the last dose of study drug. Males with female partners of child-bearing potential that are surgically sterile, or males who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception.
- Vital signs after 5 minutes resting in supine position:
- Systolic blood pressure (SBP) - 90-140 mmHg,
- Diastolic blood pressure (DBP) - 40-90 mmHg,
- Heart rate (HR) 40-100 bpm.
- At Screening and pre-inoculation with the malaria challenge agent: normal standard mean of triplicate 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges:
- QT ≤ 500 msec,
- QT Interval Corrected Using Fridericia's Formula (QTcF) QTcF ≤ 450 msec, QT Interval Corrected Using Bazett's Formula (QTcB) QTcB ≤ 450 msec
- PR interval ≤ 210 msec for both males and females, and
- Normal ECG tracing unless the Principal Investigator or delegate considers an ECG tracing abnormality to be not clinically relevant.
- 12. In the opinion of the Principal Investigator or delegate, the individual has a high probability of adherence with and completion of the study, and willing and able to withdraw and refrain from restricted medications.
- 13. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- 14. Fluent in English and able to understand and comply with written and verbal protocol-related requirements.
- 15. Agrees to adhere to the lifestyle considerations throughout the study (see Section 4.3.3) and is willing to consume 240 mL full-fat milk with each dose of rescue medication Riamet®.
Who cannot join
- Any lifetime history of malaria or participation in a previous malaria challenge study or malaria vaccine trial.
- Must not have had malaria exposure that is considered significant by the Principal Investigator or delegate. This includes but is not limited to:
- history of having travelled to or lived (> 2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the trial;
- history of having lived for >1 year in a malaria-endemic region in the past 10 years;
- history of having ever lived in a malaria-endemic region for more than 10 years inclusive. For endemic regions see https://malariaatlas.org/explorer/#/ Bali is not considered a malaria-endemic region.
- Presence of acute infectious disease and/or abnormal body temperature (defined as an a.m. tympanic temperature >37.5 ºC or a p.m. >37.7 ºC) at pre-inoculation.
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- Haematology, biochemistry or urinalysis results that are outside of the laboratory normal reference ranges and are either:
- considered clinically significant by the Principal Investigator or delegate; OR
- considered not clinically significant by the Principal Investigator or delegate but are also outside of Sponsor-approved clinically acceptable laboratory ranges
- Breastfeeding or lactating; positive serum pregnancy test at screening, positive urine pregnancy test upon admission or at other timepoints as specified by schedule of activities tables.
- Has previously received a blood transfusion.
- Use of antibiotics within 6 weeks of Screening.
- Use of systemic therapies with antimalarial activity within 6 weeks of Screening. This includes (but not limited to) artemisinin, amodiaquine, atovaquone, chloroquine, mefloquine, mepacrine, primaquine, proguanil, quinine, sulfadoxine-pyrimethamine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, doxycycline, and tafenoquine.
- Prior to screening and inoculation with the malaria challenge agent:
- any systemic administration (oral, pulmonary/nasal, IV) of corticosteroids, anti-inflammatory drugs (excluding commonly used over-the-counter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past three months.
- Ibuprofen (preferred) may be used at doses of up to 1.2 g/day, or paracetamol at doses of up to 2 g/day after discussion with the Investigator. Limited use of other non-prescription medications or dietary supplements, not believed to affect subject safety or the overall results of the study, may be permitted on a case-by-case basis following approval by the Sponsor in consultation with the Investigator.
- Any topical administration (cutaneous, eye drops) of corticosteroids within the past 2 weeks.
- Any individual currently receiving or having previously received immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past 12 months.
- Any contra-indication to rescue medication according to the applicable labelling and if found to be severely glucose-6-phosphate dehydrogenase (G6PD) deficient at screening (i.e. activity of less than 10% as per World Health Organization (WHO) definition).
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic/ gallbladder*/ bile duct, renal, metabolic, haematological, neurological, musculoskeletal, rheumatologic, systemic, ocular, gynaecologic (if female), infectious or autoimmune disease, or signs of acute illness. *including medical history of asymptomatic gallbladder stones.
- History of recurrent headache (eg, tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and severe enough to require medical therapy. History of recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly and no event requiring treatment in the last 2 weeks prior to screening).
- Any personal history of surgical procedures that may affect IMP absorption, distribution (i.e. GI surgery) and metabolism or immune response to malaria inoculation (splenectomy).
- Blood donation of any volume within one month before screening, or participation in any research study involving blood sampling (more than 450 mL/unit of blood).
- Any documented evidence of current or past cardiovascular disease including:
- cardiac arrhythmias or
- family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
- Symptomatic postural hypotension at screening irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 min when changing from supine to standing position.
- Has evidence of increased cardiovascular risk (defined as >10%, 5-year risk for those greater than 35 years of age, as determined by the Australian Absolute Cardiovascular Disease Risk Calculator (http://www.cvdcheck.org.au). Risk factors include sex, age, systolic blood pressure (mm/Hg), smoking status, total and High-density lipoprotein (HDL) cholesterol (mmol/L) and reported diabetes status. Note: The site investigator will perform cardiovascular risk calculation once all assessments have been performed, prior to eligibility.
- History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or any history of anaphylaxis or other severe allergic reactions including face, mouth, or throat swelling or any difficulty breathing. Individuals with known lactose or dairy intolerance are excluded. Volunteers with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic at the time of dosing can be enrolled in the trial.
- History of convulsion (including drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not an exclusion criterion.
- History of substance use disorder(s) within 5 years of screening and/or history of alcohol dependancy and/or any prior intravenous use of an illicit substance.
- Smoked > 1 pack of cigarettes per day for > 10 years, or who currently (within 14 days prior to screening) smokes > 5 cigarettes per day.
- Any individual who, in the judgement of the Principal Investigator or delegate, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Any individual who cannot be contacted in case of emergency.
- Any individual who is the Investigator, or delegates, research assistant, pharmacist, study coordinator, project manager, or other staff thereof, directly involved in conducting the study.
- Any individual without a good peripheral venous access.
- Participation in any investigational product study within the 12 weeks preceding inoculation with the malaria challenge agent or 5 times the half-life of the Investigational product, whichever is longer.
- Positive serology test for hepatitis B (HB) (positive Hepatitis B surface antigen (HB sAG) or anti-hepatitis B core antibody (anti-HBc Ab), hepatitis C (anti-HCV) or human immune deficiency virus (HIV) (positive for anti-HIV1 (HIV type 1) and anti-HIV2 (HIV type 2) Ab ).
- Positive urine drug test at Screening, prior to inoculation with the malaria challenge agent or prior to IMP dosing. Any drug from the list of drugs tested (such as amphetamine, barbiturates, benzodiazepines, cocaine, methamphetamine, methadone, Opiates, phencyclidine, Tetrahydrocannabinol; and their metabolites) unless there is an acceptable explanation to the Principal Investigator or delegate (eg, volunteer has stated in advance that they consumed a prescription of over the counter product which contained the detected drug) and/or the volunteer has a negative urine drug screen on retest.
- Positive alcohol screen at Screening, prior to inoculation with the malaria challenge agent or prior to IMP dosing.
- Any consumption of citrus fruits (such as grapefruit, Seville oranges) or their juices within 7 days prior to IMP administration.
- History of serious psychiatric condition that may affect participation in the study or preclude compliance with the protocol, including but not limited to: past or present psychoses, disorders requiring lithium, a history of attempted or planned suicide, more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years of Screening, regardless of whether there is no evidence of local recurrence or metastases.
- Any vaccination within 28 days of screening.
- Any medical condition that in the opinion of the Principal Investigator or delegate would jeopardize the individual's involvement in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Study to Assess the Safety, Tolerability and Antimalarial Activity of MMV533 Against Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
A Phase 1b study to assess the safety, tolerability and antimalarial activity of MMV533 against Plasmodium falciparum 3D7 blood stage infection in healthy volunteers
Read the detailed description
The study will characterise the effects of single oral doses of MMV533 on the clearance of Plasmodium falciparum 3D7 using the Induced Blood Stage Malaria (IBSM) model. This is a well-established method for obtaining useful pharmacokinetic-pharmacodynamic (PK-PD) information on anti-malarial drugs.
The study will be an open-label, pilot Volunteer Infection Study (VIS) using the IBSM model and single dose IMP. The study will be conducted in healthy malaria-naive adult volunteers infected with Plasmodium falciparum 3D7, in one cohort of approximately 12 volunteers (all receiving active treatment). From an operational perspective, the full cohort may be conducted in subgroups of up to 6 volunteers. Ascending doses will be administered in order of enrolment number (per sub-group, if applicable). Volunteers will be enrolled within a 28 day screening period to ensure volunteers meet all the inclusion criteria and none of the exclusion criteria.
On Day -8 (8 days prior to IMP administration), volunteers will attend the clinical unit to be inoculated with the malaria challenge agent containing approximately 2,800 viable human erythrocytes infected with P. falciparum 3D7 parasites. Parasitaemia will be monitored on an outpatient basis daily on Day -4, and then twice daily on Day -3, Day -2 and until admission to the clinical unit on Day -1 for eligibility check and confinement.
Volunteers will be administered IMP on Day 1 and will have safety monitoring and blood sampling for parasitaemia monitoring and PK analysis on an inpatient basis for at least 108 hours post-IMP administration. Volunteers will be discharged from the clinical unit after review of ECG, vital signs, clinical and laboratory tests safety data by the Principal Investigator or delegate, and will then attend the clinical unit on an outpatient basis regularly for continued safety monitoring and blood sampling for parasitaemia monitoring and PK analysis.
Volunteers will be administered mandatory malaria rescue medication at Day 21±3, or earlier if there is failure to clear parasites or recrudescence and at the discretion of the Principal Investigator or delegate. EOS will be on Day 28±3. Volunteers must have had at least two negative 18S qPCR (18 Svedberg quantitative polymerase chain reaction) results prior to EOS and must have completed their course of anti-malarial rescue medication.
In the event of recrudescence, blood samples will be collected prior to rescue treatment to culture parasites for drug resistance testing.
- Conditions
- Malaria
- Being tested
- MMV688533
- Keywords
- Tolerability, Safety
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMV688533Drug
Also called MMV533
Not exceeding 200mg
| Study group | Role | What they receive |
|---|---|---|
| MMV533 (single, oral doses). | Other | Approximately 12 volunteers in 1 cohort, Up to six dose levels between 10 and 160mg Receives: Drug: MMV688533 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Estimated Parasite Reduction Ratio over 48 hours (PRR48)
Measured: 48 hours
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Estimated Parasite Reduction Ratio over 48 hours (log10 PRR48)
Measured: 48 hours
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Parasite Clearance Half-life after Single Oral Dose of MMV533, by Treatment Group
Measured: 48 hours
Participants With Parasitaemia Below Limit of Quantification (LOQ)
Number of volunteers whose parasitaemia levels fall below limit of quantification (LOQ) following treatment with IMP
Measured: 48 hours
Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
The Total Number of Study Participants with Recrudescence of Asexual Parasitaemia within 30 days post inoculation
Measured: 30 days post inoculation
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
Number of participants experiencing a recrudescence after 180 hours
Measured: 180 hours post inoculation
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
Number of participants experiencing a recrudescence after 312 hours
Measured: 312 hours post inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start30 Mar 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Nucleus Network Ltd, Southern Star Research
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MD, Principal investigator, Nucleus Network Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205941
- Sponsor's protocol ID
- MMV_MMV533_20_01
- Status last verified
- Oct 2024
- First submitted
- 31 Aug 2021
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bestgen B, Jones S, Thathy V, Kuemmerle A, Barcelo C, Haouala A, Gossen D, Marx MW, Di Resta I, Szramowska M, Webster RA, Llewellyn S, Ritacco DA, Yeo T, Leroy D, Barber BE, Fidock DA, Griffin P, Lickliter J, Chalon S. Safety, tolerability, pharmacokinetics, and antimalarial activity of MMV533: a phase 1a first-in-human, randomised, ascending dose and food effect study, and a phase 1b Plasmodium falciparum volunteer infection study. Lancet Infect Dis. 2025 May;25(5):507-518. doi: 10.1016/S1473-3099(24)00664-9. Epub 2024 Dec 18.
PubMed 39708824
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess the Safety, Tolerability and Antimalarial Activity of MMV533 Against Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05205941
- Acronym / sponsor ID
- MMV_MMV533_20_01
- Conditions
- Malaria
- Keywords
- Tolerability, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Nucleus Network Ltd, Southern Star Research
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b study to assess the safety, tolerability and antimalarial activity of MMV533 against Plasmodium falciparum 3D7 blood stage infection in healthy volunteers
Detailed description
The study will characterise the effects of single oral doses of MMV533 on the clearance of Plasmodium falciparum 3D7 using the Induced Blood Stage Malaria (IBSM) model. This is a well-established method for obtaining useful pharmacokinetic-pharmacodynamic (PK-PD) information on anti-malarial drugs.
The study will be an open-label, pilot Volunteer Infection Study (VIS) using the IBSM model and single dose IMP. The study will be conducted in healthy malaria-naive adult volunteers infected with Plasmodium falciparum 3D7, in one cohort of approximately 12 volunteers (all receiving active treatment). From an operational perspective, the full cohort may be conducted in subgroups of up to 6 volunteers. Ascending doses will be administered in order of enrolment number (per sub-group, if applicable). Volunteers will be enrolled within a 28 day screening period to ensure volunteers meet all the inclusion criteria and none of the exclusion criteria.
On Day -8 (8 days prior to IMP administration), volunteers will attend the clinical unit to be inoculated with the malaria challenge agent containing approximately 2,800 viable human erythrocytes infected with P. falciparum 3D7 parasites. Parasitaemia will be monitored on an outpatient basis daily on Day -4, and then twice daily on Day -3, Day -2 and until admission to the clinical unit on Day -1 for eligibility check and confinement.
Volunteers will be administered IMP on Day 1 and will have safety monitoring and blood sampling for parasitaemia monitoring and PK analysis on an inpatient basis for at least 108 hours post-IMP administration. Volunteers will be discharged from the clinical unit after review of ECG, vital signs, clinical and laboratory tests safety data by the Principal Investigator or delegate, and will then attend the clinical unit on an outpatient basis regularly for continued safety monitoring and blood sampling for parasitaemia monitoring and PK analysis.
Volunteers will be administered mandatory malaria rescue medication at Day 21±3, or earlier if there is failure to clear parasites or recrudescence and at the discretion of the Principal Investigator or delegate. EOS will be on Day 28±3. Volunteers must have had at least two negative 18S qPCR (18 Svedberg quantitative polymerase chain reaction) results prior to EOS and must have completed their course of anti-malarial rescue medication.
In the event of recrudescence, blood samples will be collected prior to rescue treatment to culture parasites for drug resistance testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMV533 (single, oral doses). | Other | Drug: MMV688533Approximately 12 volunteers in 1 cohort, Up to six dose levels between 10 and 160mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Having given written informed consent prior to undertaking any study-related procedure.
- Male or female aged between 18 to 55 years inclusive.
- Available for the duration of the study and for 2 weeks following the End of Study Visit (EOS).
- Lives with a spouse, family member, or housemate from the time of inoculation with the malaria challenge agent through to the EOS.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
Key exclusion criteria (46 listed)
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 |
|---|---|---|
| MMV688533Also: MMV533Not exceeding 200mg | Drug | MMV533 (single, oral doses). |
Primary outcome
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Time frame: 48 hours
Estimated Parasite Reduction Ratio over 48 hours (PRR48)
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Time frame: 48 hours
Estimated Parasite Reduction Ratio over 48 hours (log10 PRR48)
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium
Time frame: 48 hours
Parasite Clearance Half-life after Single Oral Dose of MMV533, by Treatment Group
Participants With Parasitaemia Below Limit of Quantification (LOQ)
Time frame: 48 hours
Number of volunteers whose parasitaemia levels fall below limit of quantification (LOQ) following treatment with IMP
Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
Time frame: 30 days post inoculation
The Total Number of Study Participants with Recrudescence of Asexual Parasitaemia within 30 days post inoculation
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
Time frame: 180 hours post inoculation
Number of participants experiencing a recrudescence after 180 hours
The Activity of Single Oral Doses of MMV533 on Clearance of Plasmodium
Time frame: 312 hours post inoculation
Number of participants experiencing a recrudescence after 312 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39708824Bestgen B, Jones S, Thathy V, Kuemmerle A, Barcelo C, Haouala A, Gossen D, Marx MW, Di Resta I, Szramowska M, Webster RA, Llewellyn S, Ritacco DA, Yeo T, Leroy D, Barber BE, Fidock DA, Griffin P, Lickliter J, Chalon S. Safety, tolerability, pharmacokinetics, and antimalarial activity of MMV533: a phase 1a first-in-human, randomised, ascending dose and food effect study, and a phase 1b Plasmodium falciparum volunteer infection study. Lancet Infect Dis. 2025 May;25(5):507-518. doi: 10.1016/S1473-3099(24)00664-9. Epub 2024 Dec 18.
- 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.
Jason Lickliter, MD principal investigator
Nucleus Network Ltd
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 MMV688533 in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.
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 22 inclusion and 46 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 2 Dec 2024. 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 Australia. 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. 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 2 Dec 2024). 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?
The Activity of Single Oral Doses of MMV533 (Name of Investigational Medicinal Product) on Clearance of Plasmodium (time frame: 48 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205941, which also lists 1 linked publication.
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 2 Dec 2024.