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Tests treatment safety and results for Malaria, Falciparum
Official title Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants
ClinicalTrials.gov ID: NCT07011511
What this study is testing
What is MMV055 Dose 1?
MMV055 Dose 1 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for malaria, falciparum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients (Parts A and B), Wellvone®/Mepron® and/or Malarone® (Part...
- 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...
- Family history of sudden death, or family history of clinically significant cardiovascular disease, as judged by the investigator
- Systolic BP \>140 or \ 90 or \ 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
See the full eligibility criteria
Who can 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...
- 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
What rules you out
- 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 or \ 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.