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BPN-14967

Phase 1

Undisclosed | Small molecule | Other |Belite Bio, Inc|Trials Updated: Jun 18, 2021

BPN-14967 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2019

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

BPN-14967 clinical trials

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
Healthy VolunteersUnlock trial analytics

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 therapeutic being developed by Belite Bio, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications for which BPN-14967 is being developed have not been publicly disclosed.

Who is developing BPN-14967?

BPN-14967 is being developed by Belite Bio, Inc., which trades on the Nasdaq under the ticker symbol BLTE. The company is the sponsor of the clinical program evaluating this small molecule therapeutic candidate.

What phase is BPN-14967 in?

BPN-14967 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.

What clinical trials is BPN-14967 in?

BPN-14967 has been evaluated in one clinical trial: NCT04005807, titled "Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults." This completed Phase 1 study enrolled 40 healthy volunteers in the United States and used a randomized, double-blind, controlled design.

What was the design of the BPN-14967 Phase 1 trial?

The Phase 1 trial NCT04005807 evaluated escalating doses of BPN-14967 in 40 healthy adult volunteers in the United States. It was a randomized, double-blind, controlled study. The trial has been completed and assessed safety and tolerability in participants aged 18 years and older.