Recent Updates
Recently added Catalysts

CC-97489

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 16, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05065541Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy ParticipantsPHASE1 COMPLETED 32Sep 24, 2021Jan 29, 2024Feb 16, 20241 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Radiation dosimetry calculated from PET-CT images
1 day
Calculated % Injected Dose in brain and other key organs and tissues
1 day
Calculated Standard Uptake Volume in brain and other key organs and tissues
1 day
Change from baseline in SUV in the brain based on PET scans
Up to 14 days
Change from baseline in VT in the brain based on PET scans.
Up to 14 days
Secondary Endpoints
Incidence of AEs
Up to 28 days after the last dose
Incidence of serious adverse events (SAEs)
Up to 28 days after the last dose
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Day 21
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -
Interventions
NameTypeDescription
CC-97489DRUGSpecified dose on specified days
[18F]T-401DRUGSpecified dose on specified days
[11C]MK-3168DRUGSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Has a Body Mass Index (BMI) of 18.0 to 33.0 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2 * Must be healthy based on medical history, physical examination (PE), clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-...

Countries:Belgium
Unlock Eligibility Criteria