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.
Overview
- Phase
- Phase 1
- Intervention
- BEY2153
- Conditions
- Alzheimer's Disease
- Sponsor
- BeyondBio Inc.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Area Under the Curve (AUC)
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
SAD (#6 Cohort)
Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once.
Intervention: BEY2153
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.
Intervention: BEY2153
MAD (#4 Cohort)
Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days.
Intervention: BEY2153
Outcomes
Primary Outcomes
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
Maximum observed plasma concentration (Cmax)
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
Secondary Outcomes
- Incidence of Adverse Events (AEs)(Up to 48 days)
- Incidence of clinically significant changes in vital signs(Up to 18 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 48 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)
- Incidence of clinically significant changes in physical examination(Up to 18 days)