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

March 6, 2025 updated by: BeyondBio Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAD (#6 Cohort)
Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once.
Drug: BEY2153
Capsule
Experimental: SAD (#1 Cohort) - Food effect evaluation
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.
Drug: BEY2153
Capsule
Experimental: MAD (#4 Cohort)
Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days.
Drug: BEY2153
Capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 to Day 9
Day 1 to Day 9
Area Under the Curve (AUC)
Time Frame: Day 1 to Day 9
Day 1 to Day 9
Apparent terminal elimination half-life (t1/2)
Time Frame: Day 1 to Day 9
Day 1 to Day 9
Apparent clearance (CL/F)
Time Frame: Day 1 to Day 9
Day 1 to Day 9
Apparent volume of distribution (Vz/F)
Time Frame: Day 1 to Day 9
Day 1 to Day 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 48 days
Up to 48 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 48 days
Up to 48 days
Incidence of clinically significant changes in vital signs
Time Frame: Up to 18 days
Up to 18 days
Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
Time Frame: Up to 18 days
Up to 18 days
Incidence of clinically significant changes in clinical laboratory results
Time Frame: Up to 18 days
Up to 18 days
Incidence of clinically significant changes in physical examination
Time Frame: Up to 18 days
Up to 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeyondBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BEY-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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