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Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants

ConditionMalaria, Falciparum
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMedicines for Malaria Venture

About this trial

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. In Part B, up to 3 sequential cohorts of 8 healthy male participants and healthy non-pregnant, non-lactating female participants will be enrolled. In each cohort, participants will be randomised in a ratio of 6 active investigational medicinal product (IMP) to 2 placebo.

Part A of the study will include two components, Parts A1 and A2. Part A1 includes two initial cohorts, with planned doses of 40 and 100mg, respectively. It is intended to document the human elimination T1/2 of MMV055, which will then be used to shorten the proposed End of Study (EOS) of 48 weeks, if possible.

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 IMP or placebo (1 participant each) to assess safety and tolerability (including ISRs).

The sentinel group will be dosed concomitantly at least 7 days 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • MMV055 Dose 1

    Drug

    40mg

  • MMV055 Dose 2

    Drug

    100mg

  • MMV055 Dose 3

    Drug

    200mg

  • MMV055 Dose 4

    Drug

    400mg

  • MMV055 Dose 5

    Drug

    800mg

  • MMV055 Dose 6

    Drug

    TBCmg

  • Matching placebo Part A

    Drug

    Part A

  • Matching placebo Part B

    Drug

    Part B

  • MMV055/MMV371 Combo 1

    Combination product

    Combination 1

  • MMV055/MM371 Combo 2

    Combination product

    Combination 2

  • MMV055/MMV371 Combo 3

    Combination product

    Combination 3

Treatment groups

72 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Part A1 Regimen AExperimental treatment 2 interventions
Group B: Part A1 Regimen BExperimental treatment 2 interventions
Group C: Part A2 Regimen CExperimental treatment 2 interventions
Group D: Part A2 Regimen DExperimental treatment 2 interventions
Group E: Part A2 Regimen EExperimental treatment 2 interventions
Group F: Part A2 Regimen FExperimental treatment 2 interventions
Group G: Part B Combination 1Experimental treatment 2 interventions
Group H: Part B Combination 2Experimental treatment 2 interventions
Group I: Part B Combination 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety - Incidence of AEs

Number of participants with AEs

Time frame
From enrollment to the last follow up visit at week 56
2

Safety - Incidence of Injection Site Reactions

Number of participants with Injection Site Reactions

Time frame
From enrollment to the last follow up visit at week 56
3

Safety - Incidence of physical examination findings

Number of participants with physical examination findings

Time frame
From enrollment to the last follow up visit at week 56
4

Safety - Vital signs changes from baseline

Number of participants with clinically significant vital signs changes from baseline

Time frame
From enrollment to the last follow up visit at week 56

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medicines for Malaria Venture

Lead sponsor

Quotient Sciences

Collaborator

The Doctors Laboratory Ltd

Collaborator

Source ClinicalTrials.gov
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