Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults

Sponsor

Belite Bio, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04005807

Collaborator

(none)

Enrollment

Location

Arms

5.1

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BPN-14967 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of BPN-14967 in Healthy Adult Subjects

Actual Study Start Date :

Jul 19, 2019

Actual Primary Completion Date :

Dec 20, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 (fasted condition) 10 mg BPN-14967 or placebo	Drug: BPN-14967 BPN-14967 oral capsules Drug: Placebo Oral capsules
Experimental: Cohort 2 (fasted condition) 25 mg BPN-14967 or placebo	Drug: BPN-14967 BPN-14967 oral capsules Drug: Placebo Oral capsules
Experimental: Cohort 3 (fasted condition) 50 mg BPN-14967 or placebo	Drug: BPN-14967 BPN-14967 oral capsules Drug: Placebo Oral capsules
Experimental: Cohort 4 (fed condition) 10 mg BPN-14967 or placebo	Drug: BPN-14967 BPN-14967 oral capsules Drug: Placebo Oral capsules
Experimental: Cohort 5 (high-fat fed condition) 10 mg BPN-14967 or placebo	Drug: BPN-14967 BPN-14967 oral capsules Drug: Placebo Oral capsules

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
Female subjects must be of non-childbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or
bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening).
Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or agree to use a condom with spermicide when sexually active with a female partner. Male subjects must also agree to refrain from sperm donation for 90 days after study drug administration.
The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, at screening and weighs 50 to 100 kg (110-220 pounds), inclusive, at screening and Check-in.
The subject is considered to be in stable health by the investigator

Exclusion Criteria

Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
Any recent viral or bacterial infection.
Participated in any clinical study in last 6 weeks.
History of significant drug allergy
History of significant vision, ocular or retinal disorder.
Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations

Other protocol-defined inclusion/exclusion criteria could apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase I Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

Belite Bio, Inc

Investigators

Study Director: Konstantin Petrukhin, PhD, Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Belite Bio, Inc

ClinicalTrials.gov Identifier:

NCT04005807

Other Study ID Numbers:

BPN-14967-001

First Posted:

Jul 2, 2019

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 18, 2021