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MMV390048

Phase 1

Malaria | Small molecule | Infectious Disease |CNS Pharmaceuticals, Inc.|Last Updated: Jun 11, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

MMV390048 · 2 trials · 1 indication

Phase 1 2
NCT02783820Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part AMalaria
COMPLETED24 Analytics
NCT02783833MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part BMalaria
COMPLETED15 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
MalariaUnlock trial analytics
PHASE1COMPLETED
MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of MMV390048 - Number of Adverse Events
28 days post administration of a single oral dose of MMV390048 to healthy volunteers

Number of observed and self-reported Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)

Effect on parasites
28 days

The effect of a single oral dose of MMV390048 on P. falciparum blood stage parasites in healthy volunteers with induced blood stage malaria as observed over a period of 28 days post dosing, through: * qPCR analysis of parasite clearance, and * calculation of the parasite reduction ratio (PRR)

Secondary Endpoints

PK Cmax
28 days
PK Tmax
28 days
PK Total Exposure AUClast
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MMV390048 40 mgEXPERIMENTALMMV390048 40 mg, tablets, single dose
Placebo to match MMV390048 40 mgPLACEBO_COMPARATORPlacebo to match MMV390048 40 mg, tablets, single dose
MMV390048 80 mgEXPERIMENTALMMV390048 80 mg, tablets, single dose
Placebo to match MMV390048 80 mgPLACEBO_COMPARATORPlacebo to match MMV390048 80 mg, tablets, single dose
MMV390048 120 mgEXPERIMENTALMMV390048 120 mg, tablets, single dose
Placebo to match MMV390048 120 mgPLACEBO_COMPARATORPlacebo to match MMV390048 120 mg, tablets, single dose
MMV390048 dose to be determined mgEXPERIMENTALMMV390048 dose to be determined mg, tablets, single dose

Interventions

NameTypeDescription
MMV390048 40 mgDRUG -
Placebo to match MMV390048 40 mgDRUG -
MMV390048 80 mgDRUG -
Placebo to match MMV390048 80 mgDRUG -
MMV390048 120 mgDRUG -
Placebo to match MMV390048 120 mgDRUG -
MMV390048 40mgDRUG -
MMV390048 dose to be determined mgDRUGCohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Completion of the written informed consent process. 2. Men or WNCBP age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 3. Male subjects agree to use acceptable meth...

Countries:Australia
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Competitive Landscape -Malaria 6 trials

Frequently asked questions about MMV390048

What is MMV390048 used for?

MMV390048 is an investigational small molecule being developed for the treatment of malaria. It is currently in Phase 1 clinical development and has been studied in healthy adult volunteers to evaluate its safety, tolerability, and antimalarial activity against Plasmodium falciparum.

Who is developing MMV390048?

MMV390048 is being developed by CNS Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol CNSP. The drug is in Phase 1 clinical development for malaria.

What does MMV390048 target?

MMV390048 is a small molecule antimalarial agent. It has demonstrated antimalarial activity against Plasmodium falciparum in clinical studies. The specific molecular target of the drug has not been disclosed in the available clinical trial information.

What phase is MMV390048 in?

MMV390048 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy adult volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has MMV390048 been in?

MMV390048 has been studied in two completed Phase 1 clinical trials. The first trial, NCT02783820, assessed safety, tolerability, and pharmacokinetics of ascending oral doses. The second trial, NCT02783833, evaluated its antimalarial activity against Plasmodium falciparum. Both trials were conducted in Australia.

Is MMV390048 the same as other antimalarial drugs?

MMV390048 is a distinct investigational small molecule developed for malaria. It has been studied as a single agent in Phase 1 trials. No alternative names for this drug have been reported in the clinical trial records.