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
Overview
- Phase
- Phase 1
- Intervention
- BPN-14967
- Conditions
- Healthy Volunteers
- Sponsor
- Belite Bio, Inc
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to maximum observed plasma concentration (Tmax)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1 (fasted condition)
10 mg BPN-14967 or placebo
Intervention: BPN-14967
Cohort 1 (fasted condition)
10 mg BPN-14967 or placebo
Intervention: Placebo
Cohort 2 (fasted condition)
25 mg BPN-14967 or placebo
Intervention: BPN-14967
Cohort 2 (fasted condition)
25 mg BPN-14967 or placebo
Intervention: Placebo
Cohort 3 (fasted condition)
50 mg BPN-14967 or placebo
Intervention: BPN-14967
Cohort 3 (fasted condition)
50 mg BPN-14967 or placebo
Intervention: Placebo
Cohort 4 (fed condition)
10 mg BPN-14967 or placebo
Intervention: BPN-14967
Cohort 4 (fed condition)
10 mg BPN-14967 or placebo
Intervention: Placebo
Cohort 5 (high-fat fed condition)
10 mg BPN-14967 or placebo
Intervention: BPN-14967
Cohort 5 (high-fat fed condition)
10 mg BPN-14967 or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Time to maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 8
Number of participants with Ocular Examination Abnormalities
Time Frame: 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)]
Time Frame: Up to Day 8
Number of participants with Physical Examination Abnormalities
Time Frame: Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time Frame: Up to Day 10
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
Time Frame: Up to Day 8
Terminal elimination rate constant
Time Frame: Up to Day 8
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
Time Frame: Up to Day 10
Number of participants with Vital Sign Abnormalities
Time Frame: Up to Day 10
Number of participants with changes in visual acuity
Time Frame: Baseline and Day 10
Terminal phase half-life (t1/2)
Time Frame: Up to Day 8
Number of participants with changes in color vision
Time Frame: Baseline and Day 10
Maximum observed plasma concentration (Cmax)
Time Frame: Up to Day 8
Apparent total body clearance (CL/F)
Time Frame: Up to Day 8
Apparent volume of distribution (Vz/F)
Time Frame: Up to Day 8
Number of participants with Clinical Laboratory Results Abnormalities
Time Frame: Up to Day 10