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MT1980

Phase 1

Neuroinflammatory Response | Small molecule | Other |Icon Plc|Last Updated: Nov 2, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05429840Safety & PK of Single Doses of MT1980PHASE1 COMPLETED 24Jun 1, 2022Oct 4, 2022Nov 2, 20221 Netherlands
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Study Endpoints
Primary Endpoints
Treatment-related adverse events
Day 1 to Day 11

Descriptive statistics comparing MT1980 \& placebo following a single dose of study drug. Number of subjects, number of events and severity of events to be reported

Secondary Endpoints
Systemic bioavailability of MT1980
72 hours post dose
Level of MT1980 in CSF
up to 7 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part 1 MT1980EXPERIMENTAL -
Part 1 PlaceboPLACEBO_COMPARATOR -
Part 2 MT1980 Dose Level 1EXPERIMENTAL -
Part 2 MT1980 Dose Level 2EXPERIMENTAL -
Part 2 PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MT1980DRUGsingle dose
PlaceboDRUGsingle dose
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers with good physical and mental health * Body Mass Index 18 to 30 kg/m2 * Men \& women of child-bearing potential must agree to use adequate contraception * Willing \& able to provide written informed consent and to communicate and participate in the study Ex...

Countries:Netherlands
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