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A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

NCT04476303•BeyondBio Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

19 - 80 years

Sex

MALE

Healthy Volunteers

Yes

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.
+10 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

August 27, 2020

Primary Completion Date

November 23, 2021

Completion Date

November 23, 2021

Last Updated

March 10, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

BEY2153

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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