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BPN-14967

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BPN-14967 · 1 trial · 1 indication

Phase 1 1
NCT04005807Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy AdultsHealthy Volunteers
COMPLETED40 Analytics
PHASE1COMPLETED
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults
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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 to 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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Frequently asked questions about BPN-14967

What is BPN-14967?

BPN-14967 is an investigational small molecule being developed by Belite Bio, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and the completed trial evaluated its safety and tolerability.

What is BPN-14967 used for?

BPN-14967 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed the safety and tolerability of escalating doses of the drug in healthy adults. Its intended therapeutic use has not been specified.

Who makes BPN-14967?

BPN-14967 is being developed by Belite Bio, Inc, a biopharmaceutical company. The company's stock trades under the ticker symbol BLTE. Belite Bio is conducting clinical research on this investigational small molecule.

What phase is BPN-14967 in?

BPN-14967 is in Phase 1 clinical development. The Phase 1 trial, which has been completed, enrolled 40 healthy adult participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BPN-14967 in?

BPN-14967 has one completed Phase 1 clinical trial, identified as NCT04005807. The study, titled 'Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults,' was conducted in the United States with 40 participants aged 18 years and older.

Was the BPN-14967 trial randomized and controlled?

Yes, the completed Phase 1 trial of BPN-14967 was randomized, double-blind, and controlled. The study enrolled 40 healthy volunteers and was conducted in the United States. The trial has been completed, and no active trials are currently listed.