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18F-BMS-986327

Phase 1

Healthy Participants | Unknown | Respiratory |Bristol-Myers Squibb Company|Last Updated: Mar 7, 2023

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
CONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04069143A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327PHASE1 COMPLETED 14Oct 1, 2019Jul 12, 2022Mar 7, 20231 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Up to 3 days after participant's participation
Incidence of serious adverse events (SAEs)
Up to 30 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
30 days after participant's participation
Test-retest repeatability
30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
30 days after participant's participation
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -
Interventions
NameTypeDescription
18F-BMS-986327DIAGNOSTIC_TESTImaging Agent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All Participants: · Body mass index of 18.0 to 34.0 kg/m\^2, inclusive, and body weight ≥ 50 kg Healthy Participants: * Male and female healthy volunteers ages 18 or age or older * No clinically significant deviation from normal in medical history, physical examination, elect...

Countries:United States
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