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BPN-14967

Phase 1

Healthy Volunteers | Small molecule | Other |Belite Bio, Inc|Last Updated: Jun 18, 2021

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04005807Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy AdultsPHASE1 COMPLETED 40 — — Jul 19, 2019Dec 20, 2019Jun 18, 20211 United States
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Study Endpoints
Primary Endpoints
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]
Up to Day 8
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
Up to Day 8
Maximum observed plasma concentration (Cmax)
Up to Day 8
Time to maximum observed plasma concentration (Tmax)
Up to Day 8
Terminal elimination rate constant
Up to Day 8
Terminal phase half-life (t1/2)
Up to Day 8
Apparent total body clearance (CL/F)
Up to Day 8
Apparent volume of distribution (Vz/F)
Up to Day 8
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
Up to Day 10
Number of participants with Clinical Laboratory Results Abnormalities
Up to Day 10
Number of participants with Vital Sign Abnormalities
Up to Day 10
Number of participants with Physical Examination Abnormalities
Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Up to Day 10
Number of participants with changes in visual acuity
Baseline and Day 10
Number of participants with Ocular Examination Abnormalities
Up to Day 10
Number of participants with changes in color vision
Baseline and Day 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1 (fasted condition)EXPERIMENTAL10 mg BPN-14967 or placebo
Cohort 2 (fasted condition)EXPERIMENTAL25 mg BPN-14967 or placebo
Cohort 3 (fasted condition)EXPERIMENTAL50 mg BPN-14967 or placebo
Cohort 4 (fed condition)EXPERIMENTAL10 mg BPN-14967 or placebo
Cohort 5 (high-fat fed condition)EXPERIMENTAL10 mg BPN-14967 or placebo
Interventions
NameTypeDescription
BPN-14967DRUGBPN-14967 oral capsules
PlaceboDRUGOral capsules
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject is male or female (not of childbearing potential), 18 to 65 years of age, inclusive, at screening. * The subject voluntarily consents to participate in this study and * provides written informed consent before the start of any study-specific procedures. * The subje...

Countries:United States
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