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

NCT04476303 | Completed Phase 1

• 1 other identifier: BEY-2019-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (5)

• Maximum observed plasma concentration (Cmax)

  Day 1 to Day 9

• Area Under the Curve (AUC)

  Day 1 to Day 9

• Apparent terminal elimination half-life (t1/2)

  Day 1 to Day 9

• Apparent clearance (CL/F)

  Day 1 to Day 9

• Apparent volume of distribution (Vz/F)

  Day 1 to Day 9

Secondary Outcomes (6)

• Incidence of Adverse Events (AEs)

  Up to 48 days

• Incidence of Serious Adverse Events (SAEs)

  Up to 48 days

• Incidence of clinically significant changes in vital signs

  Up to 18 days

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

  Up to 18 days

• Incidence of clinically significant changes in clinical laboratory results

  Up to 18 days

Study Arms (3)

SAD (#6 Cohort)

EXPERIMENTAL

Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once.

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.

Drug: BEY2153

MAD (#4 Cohort)

EXPERIMENTAL

Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days.

Drug: BEY2153

Interventions

BEY2153 DRUG

Capsule

MAD (#4 Cohort); SAD (#1 Cohort) - Food effect evaluation; SAD (#6 Cohort)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BeyondBio Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: August 27, 2020
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)