RecruitingPhase 1NCT06535308

BnH-015B Clinical Trial in Moderate Alzheimer's Disease

A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics, Food Effect, Ethnic Difference of BnH-015B After Oral Administration in Healthy Adult Korean and Caucasian Male Volunteers and in Patients With Moderate Alzheimer's Disease

Sponsor

BnH Research

Enrollment

92 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

BnH-015B is a small molecule compound that targets the GluN2B binding site on NMDA receptors and positively modulates. BnH-015B has shown, through nonclinical trials, to improve symptoms of cognitive decline by regulating the BDNF/TRKβ and microglia-mediated IL-33/OPN signaling pathways; therefore, it is expected to be a promising new drug that can significantly improve symptoms associated with Alzheimer's disease, including memory loss.

Eligibility

Min Age: 19 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called BnH-015B in people with moderate Alzheimer's disease, and also in healthy young adults to assess safety. Part I involves healthy volunteers; Part II focuses on Alzheimer's patients to evaluate whether the drug can improve symptoms. **You may be eligible if...** - (Healthy volunteers, Part I) You are a male aged 19–45 of Korean or Caucasian background - (Alzheimer's patients, Part II) You are aged 55–85 with a confirmed Alzheimer's diagnosis, a moderate severity score, and positive biomarker tests - You weigh between 55–90 kg with a healthy BMI - A caregiver is available to support you throughout the study **You may NOT be eligible if...** - You have had a heart attack, serious heart failure, or stroke - You have another type of dementia (e.g., Lewy body, vascular dementia) - You tested positive for HIV, hepatitis B or C - You have serious liver, kidney, or other organ disease - You received a vaccine within 5 days before taking the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.