Clinical trial NCT04005807: Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Belite Bio, Inc
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

* 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.

Primary outcomes:
measure: Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]
timeFrame: Up to Day 8
measure: Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
timeFrame: Up to Day 8
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 8
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 8
measure: Terminal elimination rate constant
timeFrame: Up to Day 8
measure: Terminal phase half-life (t1/2)
timeFrame: Up to Day 8
measure: Apparent total body clearance (CL/F)
timeFrame: Up to Day 8
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to Day 8
measure: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
timeFrame: Up to Day 10
measure: Number of participants with Clinical Laboratory Results Abnormalities
timeFrame: Up to Day 10
measure: Number of participants with Vital Sign Abnormalities
timeFrame: Up to Day 10
measure: Number of participants with Physical Examination Abnormalities
timeFrame: Up to Day 10
measure: Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 10
measure: Number of participants with changes in visual acuity
timeFrame: Baseline and Day 10
measure: Number of participants with Ocular Examination Abnormalities
timeFrame: Up to Day 10
measure: Number of participants with changes in color vision
timeFrame: Baseline and Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center
name: Konstantin Petrukhin, PhD
role: STUDY_DIRECTOR
References: