Actively Recruiting
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 and in Combination With MMV371 in Healthy Participants
Led by Medicines for Malaria Venture · Updated on 2025-07-08
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medicines for Malaria Venture
Lead Sponsor
Q
Quotient Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a single-centre, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of long-acting injectable formulations of MMV055 administered alone (Part A) and combined with MMV371 (Part B) in healthy adult participants. The study focuses on healthy males and females who are not of childbearing potential or are non-pregnant and non-lactating females, with ages ranging from 18 to 60 years. The trial aims to assess these investigational treatments through carefully controlled dosing and safety monitoring. The study involves up to six sequential cohorts in Part A with doses of MMV055 ranging from 40mg to higher planned doses, including sentinel dosing for safety before wider group administration. Part B includes up to three cohorts receiving combinations of MMV055 and MMV371. Participants are randomized in a 6:2 ratio to receive either the active drug or placebo via intramuscular injection. The study includes two components in Part A (A1 and A2) to help determine the drug's half-life and optimize treatment duration. Participants will be monitored from enrollment through follow-up visits lasting up to 56 weeks. Assessments include safety evaluations such as adverse events, injection site reactions, physical exams, vital signs, ECG changes, and blood tests measuring drug concentrations. The study tracks these outcomes closely to understand the drugs' effects and tolerability over time. This long follow-up ensures thorough observation of any reactions or changes related to the treatments.
CONDITIONS
Brief Title
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 female of non-childbearing potential (Parts A and B), or healthy non-pregnant, non-lactating female participants (Part B only) as determined by medical assessment
- Body mass index (BMI) of 19.0 to 30.0 kg/m2 as measured at screening
- Weight �350 kg for males and �345 kg for females at screening
You will not qualify if you...
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Allergy requiring treatment, except active hay fever
- History of significant cardiovascular, kidney, liver, skin, respiratory, gastrointestinal, neurological, or psychiatric disease
- Family history of sudden death or significant cardiovascular disease
- Blood pressure outside 90-140 mmHg systolic or 50-90 mmHg diastolic; heart rate outside 45-100 bpm
- Abnormal findings in medical exam, vital signs, or ECG considered clinically relevant
- Known structural heart problems or significant ECG abnormalities
- History of gallstones or gallbladder removal
- Unsuitable veins for blood sampling
- Tattoos, scars, or skin conditions over injection sites
- Significant abnormal lab results or Gilbert's Syndrome
- High cholesterol, triglycerides, or fasting blood glucose levels
- Positive for hepatitis B, hepatitis C, or HIV
- Elevated liver enzymes
- Females who are pregnant, lactating, or of childbearing potential (Part A only)
- Received investigational medicinal product in past 90 days or less than 5 half-lives
- Previous administration of MMV055 or MMV371
- Blood or plasma donation within past 3 months or loss of >400 mL blood
- Use of most medications or herbal remedies within 14 days prior to dosing
- Use of rifampin, tetracycline, or indinavir within 30 days before dosing (Part B only)
- Live vaccines within 30 days or COVID-19 vaccine within 14 days before dosing
- History of drug or alcohol abuse in past 2 years
- Excessive alcohol consumption
- Current or recent smokers, e-cigarette, or nicotine replacement users
- Positive breath or drug tests at screening or admission
- Male participants with pregnant or lactating partners
- High scores for suicidal ideation or behavior
- Study site or sponsor employees and immediate family
- Any other reason judged by investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up to week 56
Participants receive a single ascending dose of the investigational drug or combination via intramuscular injection to assess safety, tolerability, and pharmacokinetics.
Multiple visits including dosing and follow-up visits over 56 weeks
Duration - Up to 56 weeks post dosing
Participants are monitored for safety, tolerability, and pharmacokinetics through scheduled visits after dosing until week 56.
Regular follow-up visits until week 56
Trial Site Locations
Total: 1 location
1
Quotient Sciences
Nottingham, United Kingdom, United Kingdom, NG11 6JS
Actively Recruiting
Research Team
S
Stephan Chalon, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
9
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