Healthy VolunteersPhase 1NCT04005807
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults
A Phase 1 study testing BPN-14967 in people with Healthy Volunteers, run by Belite Bio, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BPN-14967
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 20 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- BPN-14967, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPN-14967Drug
BPN-14967 oral capsules
PlaceboDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (fasted condition) | Experimental | 10 mg BPN-14967 or placebo Receives: Drug: BPN-14967; Drug: Placebo |
| Cohort 2 (fasted condition) | Experimental | 25 mg BPN-14967 or placebo Receives: Drug: BPN-14967; Drug: Placebo |
| Cohort 3 (fasted condition) | Experimental | 50 mg BPN-14967 or placebo Receives: Drug: BPN-14967; Drug: Placebo |
| Cohort 4 (fed condition) | Experimental | 10 mg BPN-14967 or placebo Receives: Drug: BPN-14967; Drug: Placebo |
| Cohort 5 (high-fat fed condition) | Experimental | 10 mg BPN-14967 or placebo Receives: Drug: BPN-14967; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]
Measured: Up to Day 8
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
Measured: Up to Day 8
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 8
Time to maximum observed plasma concentration (Tmax)
Measured: Up to Day 8
Terminal elimination rate constant
Measured: Up to Day 8
Terminal phase half-life (t1/2)
Measured: Up to Day 8
Apparent total body clearance (CL/F)
Measured: Up to Day 8
Apparent volume of distribution (Vz/F)
Measured: Up to Day 8
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
Measured: Up to Day 10
Number of participants with Clinical Laboratory Results Abnormalities
Measured: Up to Day 10
Number of participants with Vital Sign Abnormalities
Measured: Up to Day 10
Number of participants with Physical Examination Abnormalities
Measured: Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 10
Number of participants with changes in visual acuity
Measured: Baseline and Day 10
Number of participants with Ocular Examination Abnormalities
Measured: Up to Day 10
Number of participants with changes in color vision
Measured: Baseline and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start19 Jul 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belite Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konstantin Petrukhin, PhD, Study director, Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005807
- Sponsor's protocol ID
- BPN-14967-001
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04005807
- Acronym / sponsor ID
- BPN-14967-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Belite Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (fasted condition) | Experimental | Drug: BPN-14967, Drug: Placebo10 mg BPN-14967 or placebo |
| Cohort 2 (fasted condition) | Experimental | Drug: BPN-14967, Drug: Placebo25 mg BPN-14967 or placebo |
| Cohort 3 (fasted condition) | Experimental | Drug: BPN-14967, Drug: Placebo50 mg BPN-14967 or placebo |
| Cohort 4 (fed condition) | Experimental | Drug: BPN-14967, Drug: Placebo10 mg BPN-14967 or placebo |
| Cohort 5 (high-fat fed condition) | Experimental | Drug: BPN-14967, Drug: Placebo10 mg BPN-14967 or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPN-14967BPN-14967 oral capsules | Drug | Cohort 1 (fasted condition), Cohort 2 (fasted condition), Cohort 3 (fasted condition), Cohort 4 (fed condition), Cohort 5 (high-fat fed condition) |
| PlaceboOral capsules | Drug | Cohort 1 (fasted condition), Cohort 2 (fasted condition), Cohort 3 (fasted condition), Cohort 4 (fed condition), Cohort 5 (high-fat fed condition) |
Primary outcome
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
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
Time frame: Up to Day 8
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 8
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to Day 8
Terminal elimination rate constant
Time frame: Up to Day 8
Terminal phase half-life (t1/2)
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 Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
Time frame: Up to Day 10
Number of participants with Clinical Laboratory Results Abnormalities
Time frame: Up to Day 10
Number of participants with Vital Sign Abnormalities
Time frame: Up to Day 10
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
Number of participants with changes in visual acuity
Time frame: Baseline and Day 10
Number of participants with Ocular Examination Abnormalities
Time frame: Up to Day 10
Number of participants with changes in color vision
Time frame: Baseline and Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No. After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin Petrukhin, PhD study director
Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPN-14967 in people with Healthy Volunteers, run by Belite Bio, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.