Malaria, FalciparumPhase 1NCT07011511
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants
A Phase 1 study testing MMV055 Dose 1, MMV055 Dose 2 and MMV055 Dose 3 in people with Malaria, Falciparum, run by Medicines for Malaria Venture at 1 site in United Kingdom.
Trial summary
This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- MMV055 Dose 1, MMV055 Dose 2 and MMV055 Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2025to 2 Dec 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 60 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
- Aged 18 to 60 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements defined in the study protocol
- Healthy male or healthy WONCBP (Parts A and B), or healthy non-pregnant, non-lactating female participants (Part B only) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. Safety bloods, urinalysis, ECGs and vital signs to be re-checked at admission and/or pre-dose
- Body mass index (BMI) of 19.0 to 30.0 kg/m2 as measured at screening
- Weight ≥50 kg for males and ≥45 kg for females at screening
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients (Parts A and B), Wellvone®/Mepron® and/or Malarone® (Part B only)
- 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 GI disease, neurological or psychiatric disorder, as judged by the investigator
- Family history of sudden death, or family history of clinically significant cardiovascular disease, as judged by the investigator
- Systolic BP >140 or <90 mmHg, diastolic BP >90 or <50 mmHg, or heart rate (HR) (based on vital signs assessment) >100 or <45 bpm, confirmed by repeat assessment at screening
- Any finding in the medical examination (including BP, HR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Show all 37Show fewer
- History or presence of known structural cardiac abnormalities, family history of long QT 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 changes
- Presence of sinus node dysfunction, clinically significant PR interval prolongation (>220 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 based on the mean of the triplicate values and confirmed by single repeat assessment at screening
- Participants with a history of cholecystectomy or gall stones
- Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Participants with tattoos or scars or other significant dermatological conditions overlying the deltoid or gluteal region which may interfere with injection site assessments, as determined by the investigator or delegate at screening
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in the study protocol). Participants with Gilbert's Syndrome are not allowed
- Dyslipidaemia (cholesterol and/or triglycerides) requiring pharmacological intervention or fasting triglycerides >2.26 mmol/L, fasting cholesterol >6.20 mmol/L, low density lipoprotein cholesterol >3.75 mmol/L)
- Fasting blood glucose ≥6.1 mmol/L
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- Transaminases (ALT or AST) >ULN
- 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)
- Part A only: females of childbearing potential. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is post-menopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration ≥40 IU/L).
- 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 MMV055 in this study
- Participants who report to have previously received MMV371
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- 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, up to 800 mg ibuprofen per day, hormonal contraception or HRT) in the 14 days before IMP administration (see study protocol). Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study.
- Participants who are taking, or who have taken, rifampin/rifabutin, tetracycline and indinavir in the 30 days before IMP administration (Part B only)
- Live vaccines within 30 days of IMP administration, or plans to receive such vaccines during the study
- Participants who have had a COVID 19 vaccine within 14 days before dosing
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and in 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
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the study protocol) at screening or admission
- Male participants with pregnant or lactating partners
- A score of SI 4 to 5 (related to suicidal ideation) or any SB score (related to suicidal behaviour) as assessed using the Columbia-Suicide Severity Rating Scale (C SSRS)
- 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. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences
Nottingham, NG11 6JS
Peter Green, Project Manager, +44 (0)115 974 9000, peter.green@quotientsciences.com
Nand Singh, BSc, MD, DPM, FFPM
About this study
Official title: A First-in-Human, Single-Centre, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Intramuscular Injection(s) of Long-Acting Injectable Formulations of MMV055 Alone (Part A) and in Combination With MMV371 (Part B) in Healthy Participants
This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.
It is planned to enroll up to 6 sequential cohorts of 8 healthy male participants and healthy female participants of non-childbearing potential in Part A. In Part B, up to 3 sequential cohorts of 8 healthy male participants and healthy non-pregnant, non-lactating female participants will be enrolled. In each cohort, participants will be randomised in a ratio of 6 active investigational medicinal product (IMP) to 2 placebo.
Read more
Part A of the study will include two components, Parts A1 and A2. Part A1 includes two initial cohorts, with planned doses of 40 and 100mg, respectively. It is intended to document the human elimination T1/2 of MMV055, which will then be used to shorten the proposed End of Study (EOS) of 48 weeks, if possible.
All cohorts will follow a sentinel dosing design. On Day 1, two sentinel participants (sentinel group) will be randomly assigned to receive a single IM dose of either active IMP or placebo (1 participant each) to assess safety and tolerability (including ISRs).
The sentinel group will be dosed concomitantly at least 7 days prior to the rest of the cohort (main group). The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 5:1 ratio to assess safety and tolerability (including ISRs).
- Conditions
- Malaria, Falciparum
- Being tested
- MMV055 Dose 1, MMV055 Dose 2, MMV055 Dose 3, MMV055 Dose 4, MMV055 Dose 5
- Keywords
- Malaria, First In Human, 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.
MMV055 Dose 1Drug
40mg
MMV055 Dose 2Drug
100mg
MMV055 Dose 3Drug
200mg
MMV055 Dose 4Drug
400mg
MMV055 Dose 5Drug
800mg
MMV055 Dose 6Drug
TBCmg
Matching placebo Part ADrug
Part A
Matching placebo Part BDrug
Part B
MMV055/MMV371 Combo 1Combination product
Combination 1
MMV055/MM371 Combo 2Combination product
Combination 2
MMV055/MMV371 Combo 3Combination product
Combination 3
| Study group | Role | What they receive |
|---|---|---|
| Part A1 Regimen A | Experimental | Not described Receives: Drug: MMV055 Dose 1; Drug: Matching placebo Part A |
| Part A1 Regimen B | Experimental | Not described Receives: Drug: MMV055 Dose 2; Drug: Matching placebo Part A |
| Part A2 Regimen C | Experimental | Not described Receives: Drug: MMV055 Dose 3; Drug: Matching placebo Part A |
| Part A2 Regimen D | Experimental | Not described Receives: Drug: MMV055 Dose 4; Drug: Matching placebo Part A |
| Part A2 Regimen E | Experimental | Not described Receives: Drug: MMV055 Dose 5; Drug: Matching placebo Part A |
| Part A2 Regimen F | Experimental | Not described Receives: Drug: MMV055 Dose 6; Drug: Matching placebo Part A |
| Part B Combination 1 | Experimental | Not described Receives: Drug: Matching placebo Part B; Combination Product: MMV055/MMV371 Combo 1 |
| Part B Combination 2 | Experimental | Not described Receives: Drug: Matching placebo Part B; Combination Product: MMV055/MM371 Combo 2 |
| Part B Combination 3 | Experimental | Not described Receives: Drug: Matching placebo Part B; Combination Product: MMV055/MMV371 Combo 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of AEs
Number of participants with AEs
Measured: From enrollment to the last follow up visit at week 56
Safety - Incidence of Injection Site Reactions
Number of participants with Injection Site Reactions
Measured: From enrollment to the last follow up visit at week 56
Safety - Incidence of physical examination findings
Number of participants with physical examination findings
Measured: From enrollment to the last follow up visit at week 56
Safety - Vital signs changes from baseline
Number of participants with clinically significant vital signs changes from baseline
Measured: From enrollment to the last follow up visit at week 56
Safety - ECG changes from baseline, QT intervals
Number and percentage of participants with normal and prolonged QT intervals corrected for Fridericia's correction (i.e. QTcF) and increases in QTcF intervals from baseline
Measured: From enrollment to the last follow up visit at week 56
Safety - ECG changes from baseline, PR and QRS intervals
Number and percentage of participants with clinically significant changes in PR and QRS intervals
Measured: From enrollment to the last follow up visit at week 56
Part 1 only: plasma concentrations of MMV055: Cmax
Expressed in ng/mL
Measured: From enrollment to the last follow up visit at week 56
Part 1 only: plasma concentrations of MMV055: AUC(0-last)
Expressed in ng.h/mL
Measured: From enrollment to the last follow up visit at week 56
Part 1 only: plasma concentrations of MMV055: AUC(0-inf)
Expressed in ng.h/mL
Measured: From enrollment to the last follow up visit at week 56
Part 1 only: plasma concentrations of MMV055: T1/2
Expressed in hours
Measured: From enrollment to the last follow up visit at week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start30 Jun 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Quotient Sciences, The Doctors Laboratory Ltd
- Responsible party
- Sponsor
- Investigators
- Project Director, PhD, Study director, MMV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011511
- Sponsor's protocol ID
- MMV_MMV055_24_01_FIH
- Status last verified
- Jun 2026
- First submitted
- 19 May 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Single-Centre, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Intramuscular Injection(s) of Long-Acting Injectable Formulations of MMV055 Alone (Part A) and in Combination With MMV371 (Part B) in Healthy Participants
- ClinicalTrials.gov ID
- NCT07011511
- Acronym / sponsor ID
- MMV_MMV055_24_01_FIH
- Conditions
- Malaria, Falciparum
- Keywords
- Malaria, First In Human, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Quotient Sciences, The Doctors Laboratory Ltd
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 8 Jun 2025 (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 single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.
It is planned to enroll up to 6 sequential cohorts of 8 healthy male participants and healthy female participants of non-childbearing potential in Part A. In Part B, up to 3 sequential cohorts of 8 healthy male participants and healthy non-pregnant, non-lactating female participants will be enrolled. In each cohort, participants will be randomised in a ratio of 6 active investigational medicinal product (IMP) to 2 placebo.
Part A of the study will include two components, Parts A1 and A2. Part A1 includes two initial cohorts, with planned doses of 40 and 100mg, respectively. It is intended to document the human elimination T1/2 of MMV055, which will then be used to shorten the proposed End of Study (EOS) of 48 weeks, if possible.
All cohorts will follow a sentinel dosing design. On Day 1, two sentinel participants (sentinel group) will be randomly assigned to receive a single IM dose of either active IMP or placebo (1 participant each) to assess safety and tolerability (including ISRs).
The sentinel group will be dosed concomitantly at least 7 days prior to the rest of the cohort (main group). The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 5:1 ratio to assess safety and tolerability (including ISRs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A1 Regimen A | Experimental | Drug: MMV055 Dose 1, Drug: Matching placebo Part A |
| Part A1 Regimen B | Experimental | Drug: MMV055 Dose 2, Drug: Matching placebo Part A |
| Part A2 Regimen C | Experimental | Drug: MMV055 Dose 3, Drug: Matching placebo Part A |
| Part A2 Regimen D | Experimental | Drug: MMV055 Dose 4, Drug: Matching placebo Part A |
| Part A2 Regimen E | Experimental | Drug: MMV055 Dose 5, Drug: Matching placebo Part A |
| Part A2 Regimen F | Experimental | Drug: MMV055 Dose 6, Drug: Matching placebo Part A |
| Part B Combination 1 | Experimental | Drug: Matching placebo Part B, Combination Product: MMV055/MMV371 Combo 1 |
| Part B Combination 2 | Experimental | Drug: Matching placebo Part B, Combination Product: MMV055/MM371 Combo 2 |
| Part B Combination 3 | Experimental | Drug: Matching placebo Part B, Combination Product: MMV055/MMV371 Combo 3 |
Who may qualify
- Ages
- 18 to 60 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
- Aged 18 to 60 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements defined in the study protocol
- Healthy male or healthy WONCBP (Parts A and B), or healthy non-pregnant, non-lactating female participants (Part B only) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. Safety bloods, urinalysis, ECGs and vital signs to be re-checked at admission and/or pre-dose
Key exclusion criteria (37 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients (Parts A and B), Wellvone®/Mepron® and/or Malarone® (Part B only)
- 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 GI disease, neurological or psychiatric disorder, as judged by the investigator
- Family history of sudden death, or family history of clinically significant cardiovascular disease, as judged by the investigator
- Systolic BP >140 or <90 mmHg, diastolic BP >90 or <50 mmHg, or heart rate (HR) (based on vital signs assessment) >100 or <45 bpm, confirmed by repeat assessment 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 |
|---|---|---|
| MMV055 Dose 140mg | Drug | Part A1 Regimen A |
| MMV055 Dose 2100mg | Drug | Part A1 Regimen B |
| MMV055 Dose 3200mg | Drug | Part A2 Regimen C |
| MMV055 Dose 4400mg | Drug | Part A2 Regimen D |
| MMV055 Dose 5800mg | Drug | Part A2 Regimen E |
| MMV055 Dose 6TBCmg | Drug | Part A2 Regimen F |
| Matching placebo Part APart A | Drug | Part A1 Regimen A, Part A1 Regimen B, Part A2 Regimen C, Part A2 Regimen D, Part A2 Regimen E, Part A2 Regimen F |
| Matching placebo Part BPart B | Drug | Part B Combination 1, Part B Combination 2, Part B Combination 3 |
| MMV055/MMV371 Combo 1Combination 1 | Combination product | Part B Combination 1 |
| MMV055/MM371 Combo 2Combination 2 | Combination product | Part B Combination 2 |
| MMV055/MMV371 Combo 3Combination 3 | Combination product | Part B Combination 3 |
Primary outcome
Safety - Incidence of AEs
Time frame: From enrollment to the last follow up visit at week 56
Number of participants with AEs
Safety - Incidence of Injection Site Reactions
Time frame: From enrollment to the last follow up visit at week 56
Number of participants with Injection Site Reactions
Safety - Incidence of physical examination findings
Time frame: From enrollment to the last follow up visit at week 56
Number of participants with physical examination findings
Safety - Vital signs changes from baseline
Time frame: From enrollment to the last follow up visit at week 56
Number of participants with clinically significant vital signs changes from baseline
Safety - ECG changes from baseline, QT intervals
Time frame: From enrollment to the last follow up visit at week 56
Number and percentage of participants with normal and prolonged QT intervals corrected for Fridericia's correction (i.e. QTcF) and increases in QTcF intervals from baseline
Safety - ECG changes from baseline, PR and QRS intervals
Time frame: From enrollment to the last follow up visit at week 56
Number and percentage of participants with clinically significant changes in PR and QRS intervals
Part 1 only: plasma concentrations of MMV055: Cmax
Time frame: From enrollment to the last follow up visit at week 56
Expressed in ng/mL
Part 1 only: plasma concentrations of MMV055: AUC(0-last)
Time frame: From enrollment to the last follow up visit at week 56
Expressed in ng.h/mL
Part 1 only: plasma concentrations of MMV055: AUC(0-inf)
Time frame: From enrollment to the last follow up visit at week 56
Expressed in ng.h/mL
Part 1 only: plasma concentrations of MMV055: T1/2
Time frame: From enrollment to the last follow up visit at week 56
Expressed in hours
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 15 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Project Director, PhD study director
MMV
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 MMV055 Dose 1, MMV055 Dose 2 and MMV055 Dose 3 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 37 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 15 Jun 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 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. 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 Medical Director, MD, PhD (+41 22 555 03 00, info@mmv.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of AEs (time frame: From enrollment to the last follow up visit at week 56). The study lists 10 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 15 Jun 2026.