Actively Recruiting
Study of BnH-015B in Moderate Alzheimer's Disease Evaluating Safety, Effects, and Dosing in Korean and Caucasian Adults Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial
Led by BnH Research · Updated on 2025-01-07
92
Participants Needed
1
Research Sites
83 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating BnH-015B, a small molecule that targets the GluN2B binding site on NMDA receptors, in a phase 1 clinical trial to assess its safety and tolerability. Preclinical studies suggest BnH-015B may improve symptoms of cognitive decline by regulating specific brain signaling pathways, making it a promising potential treatment for Alzheimer's disease, particularly to address memory loss. This trial addresses the urgent need for new therapies as current treatments only temporarily ease symptoms or slow decline. The study involves multiple dosing groups of BnH-015B ranging from 5 mg to 160 mg, including placebo controls, with participants being both healthy volunteers and patients with moderate Alzheimer's disease. Different dosing regimens assess safety, pharmacokinetics, pharmacodynamics, food effects, and ethnic differences. The trial includes single and multiple dose escalations with groups of Korean and Caucasian male volunteers and patients, carefully monitored throughout the study. Participants will undergo extensive evaluations including blood tests to measure BnH-015B levels over 48 hours post-dose and monitoring for adverse events for about 14 days. Cognitive function and disease markers will be assessed in patients with Alzheimer's disease. Researchers will also track safety, tolerability, and drug effects using clinical exams, laboratory tests, and imaging. The study duration varies by group but includes close follow-up to gather comprehensive data on this investigational drug.
CONDITIONS
Official Title
BnH-015B Clinical Trial in Moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part I: Healthy Korean or Caucasian male volunteers aged 19 to 45 at screening
- Part II: Individuals aged 55 to 85 years at informed consent
- Part II: Probable Alzheimer's disease dementia diagnosis per NIA-AA guidelines with MMSE 10-19 and CDR-Global Score 2
- Part II: Positive for P-tau181 and osteopontin in serum and amyloid positive by amyloid PET
- Part II: Diagnosed with Alzheimer's within 5 years prior to screening
- Part II: Consent signed by participant or legal representative; caregiver available throughout study
- Part II: Sufficient vision, hearing, language, motor function, and understanding to follow procedures
- Parts I & II: Weight between 55.0 kg and 90.0 kg and BMI of 18.0 to 30.0 kg/m2 at screening
- Parts I & II: Fully informed and voluntarily agree to participate
- Parts I & II: Suitable for study as determined by physical exams, lab tests, and medical history
You will not qualify if you...
- Part II: History of unstable angina, myocardial infarction, advanced chronic heart failure, or significant ECG abnormalities within 1 year
- Part II: History of vascular dementia
- Part II: Dementia or cognitive impairment from causes other than Alzheimer's disease
- Part II: Psychotic symptoms primarily from non-Alzheimer's conditions
- Part II: Use of contraindicated medications during entire study
- Part II: Use of unstable-dose cognitive-impairing medications within 8 weeks prior to screening
- Part II: Vaccinated within 5 days before investigational product administration
- Parts I & II: Clinically significant diseases affecting major organ systems, except mild conditions in elderly with medication discontinuation possible
- Parts I & II: Gastrointestinal diseases or surgeries affecting study safety or pharmacokinetics
- Parts I & II: Hypersensitivity to investigational product or related drugs
- Parts I & II: Positive serum tests for hepatitis B, C, HIV, or syphilis
- Parts I & II: History of alcohol or drug abuse or positive urine drug screen
- Parts I & II: Significant neurological exam abnormalities at screening
- Parts I & II: Abnormal vital signs outside defined blood pressure ranges
- Parts I & II: QT/QTc interval > 450 msec or significant ECG rhythm abnormalities
- Parts I & II: Abnormal lab test results including elevated liver enzymes or low kidney function
- Parts I & II: Use of prescription, herbal, OTC drugs, or supplements within specified windows prior to dosing
- Parts I & II: Use of enzyme-inducing or inhibiting drugs within 1 month prior to dosing
- Parts I & II: Participation in another clinical trial within 6 months
- Parts I & II: Recent blood donation or transfusion within specified timeframes
- Parts I & II: Current smokers or unable to abstain from smoking during study
- Parts I & II: Regular excessive alcohol or caffeine consumption or inability to abstain during study
- Parts I & II: Consumption of grapefruit or related foods during study
- Parts I & II: Unusual dietary habits or inability to follow standardized diet during hospitalization
- Parts I & II: Inability or unwillingness to use contraceptives or refrain from donating sperm/eggs during and after study
- Parts I & II: Dysphagia or inability to swallow multiple pills
- Parts I & II: Other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
Research Team
W
Woosik Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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