Healthy Volunteers
Conditions
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.
Interventions
DRUGBPN-14967
BPN-14967 oral capsules
DRUGPlacebo
Oral capsules
Sponsors
Belite Bio, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed