Alzheimer's DiseasePhase 1NCT04476303
A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants
A Phase 1 study testing BEY2153 in people with Alzheimer's Disease, run by BeyondBio Inc. at 1 site in South Korea.
Trial summary
This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153. Read more about this study
- Who is it for?
- Ages 19 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- BEY2153
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2020to 23 Nov 2021
- 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 19 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adult: A healthy Korean male aged 19 to 45 (inclusive) years at the time of screening Elderly adult: A healthy Korean male aged over 65 (inclusive) years at the time of screening"
- Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2 (inclusive) at screening.
- Subjects who have listened to the detailed description of this clinical trial and have fully understood, and who have agreed in writing to voluntarily participate and observe the precautions prior to receiving any of the screening procedures
- Subjects who is eligible for this clinical trial by the investigator's judgement with laboratory test results and physical-examination findings and etc.
Who cannot join
- Young adult / Elderly adult: Subjects with evidence or a history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine or hematological, neoplastic, cardiovascular, psychiatric diseases (mood disorder, obsessive-compulsive disorder etc.).
- Subjects with evidence or a history of gastrointestinal disease or with history of gastrointestinal surgery that may affect assessment of safety, PK characteristics of study drug.
- Subjects who showed significant abnormalities at neurologic examination at screening visit.
- Subjects who showed any abnormalities at vital signs
- Subjects who showed any abnormalities at blood test
- Subjects with serum AST (SGOT) or ALT (SGPT) level or total bilirubin exceed 1.5 times the upper limit of the normal range at screening
Show all 20Show fewer
- Subjects who showed any abnormalities at ECG subsection
- Subjects who are hypersensitive to drugs, or who have clinically significant hypersensitivity reactions history.
- Subjects with a history of alcohol or drug abuse or subjects who showed positive results for abuse drug at urine drug screening test.
- Subjects who consume alcohol continuously or who are unable to abstain from drinking from the time of consent until the end of the clinical trial.
- Smokers
- Subjects who had recessive disease, symptomatic infection, virus, bacteria or fungus infection 1 week before the first study drug administration.
- Subjects who have taken any prescribed drug or herbal medicine within two weeks prior to the first study drug administration. Non-prescribed medicine (OTC) or vitamin supplement prohibit within one week prior to the first study drug administration or subjects whose administrations are predicted.
- Subjects who have participated and taken investigational drug in any other clinical trial within six months prior to study drug administration
- Subjects who showed positive result for HBs antigen, HCV antibody, HIV antigen-antibody test at screening
- Subjects who had whole blood donation, apheresis or blood transfusion within 3 months before the first study drug administration.
- Subjects who had grapefruit containing food from 3 days before the scheduled date of the first study drug administration to discharge and those who cannot be prevented from taking it during the study period.
- Subjects who consume or are unable to abstain from products containing caffeine from 3 days before the scheduled date of the first study drug administration to discharge, and those who cannot be prevented from taking it during the study period.
- Subjects who do not agree to use following medically appropriate method of contraception and not to donate sperm starting from subject enrollment to 90 days after last administration of investigational product.
- Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of BEY2153 After Oral Administration in Healthy Young and Elderly Male Volunteers.
This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.
Read the detailed description
Healthy young and elderly adult volunteers who meet the criteria, will be treated single and multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be conducted with single ascending dose. After the single ascending dose study, independent external experts will review blinded data and multiple ascending dose study will be conducted.
- Conditions
- Alzheimer's Disease
- Being tested
- BEY2153
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEY2153Drug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| SAD (#6 Cohort) | Experimental | Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once. Receives: Drug: BEY2153 |
| SAD (#1 Cohort) - Food effect evaluation | Experimental | Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo for two periods at 7 days interval, with both fasting and after high fat meal. Receives: Drug: BEY2153 |
| MAD (#4 Cohort) | Experimental | Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days. Receives: Drug: BEY2153 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Day 1 to Day 9
Area Under the Curve (AUC)
Measured: Day 1 to Day 9
Apparent terminal elimination half-life (t1/2)
Measured: Day 1 to Day 9
Apparent clearance (CL/F)
Measured: Day 1 to Day 9
Apparent volume of distribution (Vz/F)
Measured: Day 1 to Day 9
Secondary outcomes (6)
Incidence of Adverse Events (AEs)
Measured: Up to 48 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 48 days
Incidence of clinically significant changes in vital signs
Measured: Up to 18 days
Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
Measured: Up to 18 days
Incidence of clinically significant changes in clinical laboratory results
Measured: Up to 18 days
Incidence of clinically significant changes in physical examination
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start27 Aug 2020
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeyondBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476303
- Sponsor's protocol ID
- BEY-2019-01
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2020
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of BEY2153 After Oral Administration in Healthy Young and Elderly Male Volunteers.
- ClinicalTrials.gov ID
- NCT04476303
- Acronym / sponsor ID
- BEY-2019-01
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- BeyondBio Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 20 Jul 2020 (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 a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.
Detailed description
Healthy young and elderly adult volunteers who meet the criteria, will be treated single and multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be conducted with single ascending dose. After the single ascending dose study, independent external experts will review blinded data and multiple ascending dose study will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAD (#6 Cohort) | Experimental | Drug: BEY2153Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once. |
| SAD (#1 Cohort) - Food effect evaluation | Experimental | Drug: BEY2153Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo for two periods at 7 days interval, with both fasting and after high fat meal. |
| MAD (#4 Cohort) | Experimental | Drug: BEY2153Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Young adult: A healthy Korean male aged 19 to 45 (inclusive) years at the time of screening Elderly adult: A healthy Korean male aged over 65 (inclusive) years at the time of screening"
- Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2 (inclusive) at screening.
- Subjects who have listened to the detailed description of this clinical trial and have fully understood, and who have agreed in writing to voluntarily participate and observe the precautions prior to receiving any of the screening procedures
- Subjects who is eligible for this clinical trial by the investigator's judgement with laboratory test results and physical-examination findings and etc.
Key exclusion criteria (20 listed)
- Young adult / Elderly adult: Subjects with evidence or a history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine or hematological, neoplastic, cardiovascular, psychiatric diseases (mood disorder, obsessive-compulsive disorder etc.).
- Subjects with evidence or a history of gastrointestinal disease or with history of gastrointestinal surgery that may affect assessment of safety, PK characteristics of study drug.
- Subjects who showed significant abnormalities at neurologic examination at screening visit.
- Subjects who showed any abnormalities at vital signs
- Subjects who showed any abnormalities at blood test
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 |
|---|---|---|
| BEY2153Capsule | Drug | MAD (#4 Cohort), SAD (#1 Cohort) - Food effect evaluation, SAD (#6 Cohort) |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 9
Area Under the Curve (AUC)
Time frame: Day 1 to Day 9
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 to Day 9
Apparent clearance (CL/F)
Time frame: Day 1 to Day 9
Apparent volume of distribution (Vz/F)
Time frame: Day 1 to Day 9
6 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 48 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 48 days
Incidence of clinically significant changes in vital signs
Time frame: Up to 18 days
Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory results
Time frame: Up to 18 days
Incidence of clinically significant changes in physical examination
Time frame: Up to 18 days
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 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 BEY2153 in people with Alzheimer's Disease, run by BeyondBio Inc. at 1 site in South Korea.
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 4 inclusion and 20 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 10 Mar 2025. 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 South Korea. 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?
Maximum observed plasma concentration (Cmax) (time frame: Day 1 to Day 9). The study lists 5 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 10 Mar 2025.