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KUR-101

Phase 1

Acute Pain | Small molecule | Pain |AtaiBeckley Inc.|Last Updated: Dec 14, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05114265A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy AdultsPHASE1 COMPLETED 60Feb 15, 2022Oct 12, 2022Dec 14, 20221 New Zealand
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Study Endpoints
Primary Endpoints
Part 1: Safety of KUR-101 when compared with placebo
From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3

Measured by the incidence of treatment-emergent adverse events

Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo
Up to 4 hours post dose

Measured using the cold pressor test

Secondary Endpoints
Part 1 and Part 2: Pharmacokinetics of KUR-101
Up to 48 hours post dose
Part 1: Pharmacokinetics of KUR-101
Up to 48 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo
Up to 8 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Single ascending doseEXPERIMENTALSingle dose of oral KUR-101 or oral placebo
Part 2: Three-way crossoverEXPERIMENTALSingle dose of oral KUR-101, oral placebo and oral OxyNorm
Interventions
NameTypeDescription
KUR-101DRUGSingle oral dose of KUR-101
OxyNormDRUGSingle oral dose of OxyNorm
PlaceboDRUGSingle oral dose of placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects; * Between 18 and 55 years of age; * Provide a signed EC-approved consent form; * Generally healthy, in the opinion of the Investigator; * Body Mass Index (BMI) 18 to 32 kg/m\^2; * Using method of contraception; * Willing and able to comply wit...

Countries:New Zealand
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