Malaria,FalciparumPhase 1NCT06558643
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants
A Phase 1 study testing MMV371 LAI in people with Malaria,Falciparum, run by Medicines for Malaria Venture at 1 site in United Kingdom.
Trial summary
This four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- MMV371 LAI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2024to 3 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 64 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 64 years inclusive at the time of signing informed consent
- 4. Must agree to adhere to the contraception requirements defined in Section 9.4 of the Protocol 5. Healthy males or non-pregnant, non-lactating healthy females, determined by normal physical examination, safety bloods, urinalysis, ECG and vital sign assessments 6. Body mass index (BMI) of 19.0 to 32.0 kg/m2 as measured at screening 7. 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, Wellvone®/Mepron® and/or Malarone®
- 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 (BP; supine) at screening or pre-dose outside the range of 90 to 140 mmHg systolic BP in participants ≤45 years, 90 to 150 mmHg SBP in participants >45 years or 50 to 90 mmHg diastolic BP; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
- 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 interval 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.
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- 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 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 Appendix 1). 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.
- 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).
- 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
- 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 Section 11.4). 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
- 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 Appendix 1) 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) at screening.
- 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.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A First-in-Human, Single-Centre, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of a Single Intramuscular Injection of MMV371 Long-Acting Injection Formulation in Healthy Participants
This four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.
For Cohort 1, up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
Read more
For Cohort 2, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 3, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 4, if the safety and tolerability results from Cohort 3 are satisfactory, up to 8 participants will be randomly assigned to receive a single dose 1.5 higher than Cohort 3 dose, administered as two IM injections, each at different anatomical locations (one in each deltoid muscle).
Participants' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. When in the clinical unit, the injection site will be checked daily for reactions, and a diary will be provided on discharge for further recording. Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for safety assessments to be performed. Participants are expected to be involved in this study for approximately 12 weeks for all study activities, from screening to the final return visit.
Read the detailed description
This is a single-centre, participant- and investigator-blind, randomised, placebo-controlled, single ascending dose (SAD) study to assess the safety, tolerability and PK of a single intra-muscular depot injection of MMV371 long-acting injection (LAI) formulation in healthy participants.
It is planned to enrol 4 sequential cohorts of up to 8 healthy male participants and healthy non-pregnant, non-lactating female participants. In each cohort, participants will be randomised in a ratio of 6 active IMP to 2 placebo.
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 investigational medicinal product (IMP) or placebo (1 participant each) to assess safety (with a focus on acute severe toxicity) and tolerability, including injection site reactions (ISRs).
The sentinel group will be dosed concomitantly at least 48 h 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).
An interim data review of the safety, tolerability (including ISRs), and PK data obtained up to Day 15 for each cohort will be conducted prior to the dose decision for the subsequent cohort(s). Should the data suggest that it is safe to proceed to the next dose group, progression to that group will be permitted.
The starting dose will be 112 mg MMV371, and dose escalation between SAD cohorts will be a maximum of 2-fold. No dose selected will exceed 669 mg MMV371.
- Cohort 1 will receive Regime A : MMV371 (112 mg (0.5 mL)), or placebo.
- Cohort 2 will receive Regime B: MMV371 (223 mg (1.0 mL)), or placebo.
- Cohort 3 will receive Regime C: MMV371 (446 mg (2.0 mL)), or placebo.
- Cohort 4 will receive Regime D: MMV371 (669 mg (3.0 mL as 2 x 1.5 mL)), or placebo.
In each cohort, participants will be dosed on Day 1 and will remain residents in the clinical unit until discharge on Day 6. They will be required to return to the clinical unit on Days 8, 10, 12, 15, 18, 23, 29, and Week 8 for the assessments detailed in the schedule of assessments and Week 12 for the end-of-study assessment.
For all parts, blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study. Participants will also be trained to complete an Injection Site Reaction Diary(ISRD) whilst resident in the clinical unit. They will receive an ISRD at discharge on Day 6 and at each return visit until the EOS visit. The ISRD should be completed at home to document new, changing or re-appearing ISRs on non-visit days/weeks; changes at the injection site or the re-appearance of an ISR(s) should be recorded in the diary whenever they occur.
- Conditions
- Malaria,Falciparum
- Being tested
- MMV371 LAI, Placebo for MMV371
- Keywords
- Malaria, First in Human, Healthy Volunteers, Long Acting Injection
- 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.
MMV371 LAIDrug
Single intra-muscular dose
Placebo for MMV371Drug
Single intramuscular dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Single Ascending Dose Regime A | Experimental | MMV371 Long-acting injection (LAI) 112mg (0.5 ml) or Placebo for MMV371 Long-acting injection(0.5 ml) Receives: Drug: MMV371 LAI; Drug: Placebo for MMV371 |
| Cohort 2 Single Ascending Dose Regime B | Experimental | MMV371 Long-acting injection (LAI) 223mg (1.0 ml) or Placebo for MMV371 Long-acting injection (1.0 ml) Receives: Drug: MMV371 LAI; Drug: Placebo for MMV371 |
| Cohort 3 Single Ascending Dose Regime C | Experimental | MMV371 Long-acting injection (LAI) 446mg (2.0 ml) or Placebo for MMV371 Long-acting injection (2.0 ml) Receives: Drug: MMV371 LAI; Drug: Placebo for MMV371 |
| Cohort 4 Single Ascending Dose Regime D | Experimental | MMV371 Long-acting injection (LAI) 669mg (3.0 ml) or Placebo for MMV371 Long-acting injection (3.0 ml) Receives: Drug: MMV371 LAI; Drug: Placebo for MMV371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) as assessed by the investigators.
AEs (including SAEs), whether ascribed to study procedures or not, will be recorded from the time of providing written informed consent until the EOS visit/unscheduled follow-up visit. Participants will be asked to self-report any new, changing or re-appearing AEs in the 30 days after the Week 12 EOS visit.
Only the drug related treatment emergent adverse events will be reported.
Measured: Screening/Day-28 up to 30 days after end of study (EOS) visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start27 Aug 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Four cohort, single ascending dose, randomised, double-blinded, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
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
- Nand Singh, MD DPM FFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558643
- Sponsor's protocol ID
- MMV_MMV371_23_01_FIH
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 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 a Single Intramuscular Injection of MMV371 Long-Acting Injection Formulation in Healthy Participants
- ClinicalTrials.gov ID
- NCT06558643
- Acronym / sponsor ID
- MMV_MMV371_23_01_FIH
- Conditions
- Malaria,Falciparum
- Keywords
- Malaria, First in Human, Healthy Volunteers, Long Acting Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Quotient Sciences, The Doctors Laboratory Ltd
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 19 Aug 2024 (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 four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.
For Cohort 1, up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 2, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 3, if the safety and tolerability results from Cohort 1 are satisfactory, up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.
For Cohort 4, if the safety and tolerability results from Cohort 3 are satisfactory, up to 8 participants will be randomly assigned to receive a single dose 1.5 higher than Cohort 3 dose, administered as two IM injections, each at different anatomical locations (one in each deltoid muscle).
Participants' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. When in the clinical unit, the injection site will be checked daily for reactions, and a diary will be provided on discharge for further recording. Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for safety assessments to be performed. Participants are expected to be involved in this study for approximately 12 weeks for all study activities, from screening to the final return visit.
Detailed description
This is a single-centre, participant- and investigator-blind, randomised, placebo-controlled, single ascending dose (SAD) study to assess the safety, tolerability and PK of a single intra-muscular depot injection of MMV371 long-acting injection (LAI) formulation in healthy participants.
It is planned to enrol 4 sequential cohorts of up to 8 healthy male participants and healthy non-pregnant, non-lactating female participants. In each cohort, participants will be randomised in a ratio of 6 active IMP to 2 placebo.
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 investigational medicinal product (IMP) or placebo (1 participant each) to assess safety (with a focus on acute severe toxicity) and tolerability, including injection site reactions (ISRs).
The sentinel group will be dosed concomitantly at least 48 h 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).
An interim data review of the safety, tolerability (including ISRs), and PK data obtained up to Day 15 for each cohort will be conducted prior to the dose decision for the subsequent cohort(s). Should the data suggest that it is safe to proceed to the next dose group, progression to that group will be permitted.
The starting dose will be 112 mg MMV371, and dose escalation between SAD cohorts will be a maximum of 2-fold. No dose selected will exceed 669 mg MMV371.
- Cohort 1 will receive Regime A : MMV371 (112 mg (0.5 mL)), or placebo.
- Cohort 2 will receive Regime B: MMV371 (223 mg (1.0 mL)), or placebo.
- Cohort 3 will receive Regime C: MMV371 (446 mg (2.0 mL)), or placebo.
- Cohort 4 will receive Regime D: MMV371 (669 mg (3.0 mL as 2 x 1.5 mL)), or placebo.
In each cohort, participants will be dosed on Day 1 and will remain residents in the clinical unit until discharge on Day 6. They will be required to return to the clinical unit on Days 8, 10, 12, 15, 18, 23, 29, and Week 8 for the assessments detailed in the schedule of assessments and Week 12 for the end-of-study assessment.
For all parts, blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study. Participants will also be trained to complete an Injection Site Reaction Diary(ISRD) whilst resident in the clinical unit. They will receive an ISRD at discharge on Day 6 and at each return visit until the EOS visit. The ISRD should be completed at home to document new, changing or re-appearing ISRs on non-visit days/weeks; changes at the injection site or the re-appearance of an ISR(s) should be recorded in the diary whenever they occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Four cohort, single ascending dose, randomised, double-blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Single Ascending Dose Regime A | Experimental | Drug: MMV371 LAI, Drug: Placebo for MMV371MMV371 Long-acting injection (LAI) 112mg (0.5 ml) or Placebo for MMV371 Long-acting injection(0.5 ml) |
| Cohort 2 Single Ascending Dose Regime B | Experimental | Drug: MMV371 LAI, Drug: Placebo for MMV371MMV371 Long-acting injection (LAI) 223mg (1.0 ml) or Placebo for MMV371 Long-acting injection (1.0 ml) |
| Cohort 3 Single Ascending Dose Regime C | Experimental | Drug: MMV371 LAI, Drug: Placebo for MMV371MMV371 Long-acting injection (LAI) 446mg (2.0 ml) or Placebo for MMV371 Long-acting injection (2.0 ml) |
| Cohort 4 Single Ascending Dose Regime D | Experimental | Drug: MMV371 LAI, Drug: Placebo for MMV371MMV371 Long-acting injection (LAI) 669mg (3.0 ml) or Placebo for MMV371 Long-acting injection (3.0 ml) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study Aged 18 to 64 years inclusive at the time of signing informed consent
- 4. Must agree to adhere to the contraception requirements defined in Section 9.4 of the Protocol 5. Healthy males or non-pregnant, non-lactating healthy females, determined by normal physical examination, safety bloods, urinalysis, ECG and vital sign assessments 6. Body mass index (BMI) of 19.0 to 32.0 kg/m2 as measured at screening 7. Weight ≥50 kg for males and ≥45 kg for females at screening
Key exclusion criteria (29 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients, Wellvone®/Mepron® and/or Malarone®
- 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 (BP; supine) at screening or pre-dose outside the range of 90 to 140 mmHg systolic BP in participants ≤45 years, 90 to 150 mmHg SBP in participants >45 years or 50 to 90 mmHg diastolic BP; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator
- 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 interval changes
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 |
|---|---|---|
| MMV371 LAISingle intra-muscular dose | Drug | Cohort 1 Single Ascending Dose Regime A, Cohort 2 Single Ascending Dose Regime B, Cohort 3 Single Ascending Dose Regime C, Cohort 4 Single Ascending Dose Regime D |
| Placebo for MMV371Single intramuscular dose | Drug | Cohort 1 Single Ascending Dose Regime A, Cohort 2 Single Ascending Dose Regime B, Cohort 3 Single Ascending Dose Regime C, Cohort 4 Single Ascending Dose Regime D |
Primary outcome
Number of participants with adverse events (AEs) as assessed by the investigators.
Time frame: Screening/Day-28 up to 30 days after end of study (EOS) visit.
AEs (including SAEs), whether ascribed to study procedures or not, will be recorded from the time of providing written informed consent until the EOS visit/unscheduled follow-up visit. Participants will be asked to self-report any new, changing or re-appearing AEs in the 30 days after the Week 12 EOS visit. Only the drug related treatment emergent adverse events will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nand Singh, MD DPM FFPM principal investigator
Quotient Sciences
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 MMV371 LAI 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 3 inclusion and 29 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 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants with adverse events (AEs) as assessed by the investigators. (time frame: Screening/Day-28 up to 30 days after end of study (EOS) visit.). 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 5 May 2026.