Phase 1 Study (QSC301763)

• Research type

  Research Study

• Full 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

• IRAS ID

  1011839

• Contact name

  Benoit Bestgen

• Contact email

  bestgenb@mmv.org

• Sponsor organisation

  Medicines for Malaria Venture

• Clinicaltrials.gov Identifier

  NCT07011511

• Research summary

  The Sponsor is developing the test medicine, MMV055, as an intramuscular long-acting injection for the prevention of malaria. Malaria is a life-threatening infection that is spread to people by mosquitoes, and if left untreated can lead to death. In this study, we’ll give healthy volunteers a single dose of MMV055, alone (Part A), or in combination with another test medicine, MMV371 (Part B), to find out its side effects and blood levels when given as a long-acting injection.

  MMV055 hasn’t been given to humans before. We’ll start with a low dose and test higher doses as the study progresses. MMV371 has been given to 18 healthy volunteers as single doses up to 446 mg and doses given so far have been safe and well tolerated.

  In this study in healthy volunteers, we aim to answer these questions.
  *Does the test medicine cause any important side effects when given alone (Part A) or in combination with MMV371 (Part B)?
  *How much test medicine enters the bloodstream and how quickly does the body get rid of it when it is given alone (Part A) or in combination with MMV371 (Part B)?

  We hope that by developing this new test medicine to be injected directly into the muscle, it will be released slowly, and as a result be effective over a longer period than medicines that currently prevent malaria. We hope that the test medicine will reduce the number of times a person would be required to take medicine to prevent malaria, when compared to medicines that are currently available, and involve taking numerous tablets.

  This study will take place at 1 site in Nottingham.

  We plan to enrol 72 healthy men and women aged 18-60 years.

  Volunteers will receive a single dose of test medicine, by injection into a muscle. They’ll stay in the clinic for up to 7 nights, attend up to 17 outpatient visits, and take up to 96 weeks to finish the study.

  We’ll collect blood and urine samples to:
  *do safety tests
  *measure the amount of test medicine and its breakdown products

• REC name

  London - Brent Research Ethics Committee

• REC reference

  25/LO/0191

• Date of REC Opinion

  5 Jun 2025

• REC opinion

  Further Information Favourable Opinion