Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371-LAI(QSC300760)

• Research type

  Research Study

• Full 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

• IRAS ID

  1008488

• Contact name

  Benoît Bestgen

• Contact email

  bestgenb@mmv.org

• Sponsor organisation

  Medicines for Malaria Venture (MMV)

• Clinicaltrials.gov Identifier

  NCT06558643

• Research summary

  The Sponsor is developing the test medicine, MMV371, as a long-acting injection for the prevention of malaria in adults and children. Malaria is a life-threatening infection that is spread to people by mosquitoes. If left untreated, malaria can lead to death. According to the World Health Organization (WHO), an estimated 619,000 people died of malaria in 2021.

  In this study, we’ll give healthy volunteers a single dose of the test medicine, to find out its side effects and blood levels when given as a long-acting injection.

  The test medicine hasn’t been given to humans before. However, when MMV371 enters the body, it is quickly broken down to atovaquone (ATV). ATV is a component of a licenced medication, known as Malarone®, that is already prescribed as tablets for the prevention of malaria. In this study, we’ll start with a low dose of MMV371 and test higher doses as the study progresses.

  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 new test medicine will reduce the number of times a person would be required to take medicine to prevent or treat malaria, when compared to medicines that are currently available, and involve taking numerous tablets.

  This study will take place at 1 non-NHS site in Nottingham.

  We plan to enroll 24 healthy men and women aged 18-64 years.

  Volunteers will receive a single dose of test medicine, by injection into deltoid muscle. They’ll stay in the clinic for up to 6 nights, attend 9 return visits, and take up to 16 weeks to finish the study.

  We plan to test up to 3 dose levels of the test medicine. Each dose level will be tested in a group of 8 volunteers, 2 of whom will receive placebo.

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

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  24/LO/0468

• Date of REC Opinion

  12 Aug 2024

• REC opinion

  Further Information Favourable Opinion