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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BPN-14967; Drug: Placebo

• Registration Number: NCT04005807
• Lead Sponsor: Belite Bio, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-07-19
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 5 (high-fat fed condition)	BPN-14967	10 mg BPN-14967 or placebo
Cohort 2 (fasted condition)	BPN-14967	25 mg BPN-14967 or placebo
Cohort 2 (fasted condition)	Placebo	25 mg BPN-14967 or placebo
Cohort 1 (fasted condition)	BPN-14967	10 mg BPN-14967 or placebo
Cohort 1 (fasted condition)	Placebo	10 mg BPN-14967 or placebo
Cohort 3 (fasted condition)	BPN-14967	50 mg BPN-14967 or placebo
Cohort 4 (fed condition)	Placebo	10 mg BPN-14967 or placebo
Cohort 3 (fasted condition)	Placebo	50 mg BPN-14967 or placebo
Cohort 5 (high-fat fed condition)	Placebo	10 mg BPN-14967 or placebo
Cohort 4 (fed condition)	BPN-14967	10 mg BPN-14967 or placebo

Primary Outcome Measures

Name	Time	Method
Number of participants with changes in color vision	Baseline and Day 10
Time to maximum observed plasma concentration (Tmax)	Up to Day 8
Number of participants with Ocular Examination Abnormalities	Up to Day 10
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
Number of participants with Physical Examination Abnormalities	Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities	Up to Day 10
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]	Up to Day 8
Terminal elimination rate constant	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 Vital Sign Abnormalities	Up to Day 10
Number of participants with changes in visual acuity	Baseline and Day 10
Terminal phase half-life (t1/2)	Up to Day 8
Maximum observed plasma concentration (Cmax)	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 Clinical Laboratory Results Abnormalities	Up to Day 10

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States