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CompletedPhase 1

A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants

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.

Lead sponsor

BeyondBio Inc.

Asset

BEY2153

Listed sites

1

Recruiting sites

-

Enrollment

88

actual

Study population

Alzheimer’s disease

Key I/E criteria

Age 19-80Male

Primary endpoints

CmaxArea Under the Curve (AUC)Apparent terminal elimination half-life (t1/2)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBEY-2019-01
NCT IDNCT04476303

Timeline

Milestones

Study first posted2020-07-20actual
Study start2020-08-27actual
Primary completion2021-11-23actual
Study completion2021-11-23actual
Last update posted2025-03-10actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age19 Years
Maximum age80 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. 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"

2. Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2 (inclusive) at screening.

3. 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

4. Subjects who is eligible for this clinical trial by the investigator's judgement with laboratory test results and physical-examination findings and etc

Exclusion criteria

1. 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.).

2. 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.

3. Subjects who showed significant abnormalities at neurologic examination at screening visit.

4. Subjects who showed any abnormalities at vital signs

5. Subjects who showed any abnormalities at blood test

6. 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

7. Subjects who showed any abnormalities at ECG subsection

8. Subjects who are hypersensitive to drugs, or who have clinically significant hypersensitivity reactions history.

9. Subjects with a history of alcohol or drug abuse or subjects who showed positive results for abuse drug at urine drug screening test.

10. 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.

11. Smokers

12. Subjects who had recessive disease, symptomatic infection, virus, bacteria or fungus infection 1 week before the first study drug administration.

13. 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.

14. Subjects who have participated and taken investigational drug in any other clinical trial within six months prior to study drug administration

15. Subjects who showed positive result for HBs antigen, HCV antibody, HIV antigen-antibody test at screening

16. Subjects who had whole blood donation, apheresis or blood transfusion within 3 months before the first study drug administration.

17. 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.

18. 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.

19. 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.

20. Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
7
Other (unclassified)
4

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Maximum observed plasma concentration (Cmax)

Time frame:Day 1 to Day 9

concentration, descriptive

Primary/protocol endpoint

Area Under the Curve (AUC)

Time frame:Day 1 to Day 9

concentration, descriptive

Primary/protocol endpoint

Apparent terminal elimination half-life (t1/2)

Time frame:Day 1 to Day 9

concentration, descriptive

Secondary/protocol endpoint

Incidence of Adverse Events (AEs)

Time frame:Up to 48 days

event count, event

Secondary/protocol endpoint

Incidence of Serious Adverse Events (SAEs)

Time frame:Up to 48 days

event count, event

Secondary/protocol endpoint

Incidence of clinically significant changes in vital signs

Time frame:Up to 18 days

event count, event

Secondary/protocol endpoint

Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters

Time frame:Up to 18 days

event count, event

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Apparent clearance (CL/F)

Time frame:Day 1 to Day 9

descriptive

Primary/protocol endpoint/low confidence

Apparent volume of distribution (Vz/F)

Time frame:Day 1 to Day 9

descriptive

Secondary/protocol endpoint/low confidence

Incidence of clinically significant changes in clinical laboratory results

Time frame:Up to 18 days

event count, event

Secondary/protocol endpoint/low confidence

Incidence of clinically significant changes in physical examination

Time frame:Up to 18 days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.