Phase 1 Alzheimer's Disease Trial, Recruiting

Part II only:

• People who have had unstable chest pain (angina), a heart attack, advanced heart failure (classified as NYHA Class III or IV), or a clinically significant heart rhythm problem within the year before screening
• People with a history of vascular dementia (memory loss caused by reduced blood flow to the brain)
• People whose dementia or cognitive impairment is caused by something other than Alzheimer's disease, such as serious head injury, alcohol-related brain damage, frontotemporal dementia, Huntington's disease, Parkinson's disease, Lewy body dementia, significant stroke-related brain disease, or serious seizure disorders
• People whose psychotic symptoms (such as hallucinations or delusions) are primarily caused by a condition other than Alzheimer's disease, such as schizophrenia or certain mood disorders
• People who are required to take medications that are not compatible with the trial drug throughout the entire study period
• People who have been taking certain medications that can affect thinking or memory — such as antidepressants, anti-seizure medications, antipsychotics, or benzodiazepines — at an unstable dose for less than 8 weeks before the screening visit
• People who have received any vaccine (including COVID-19 vaccines or booster shots) within 5 days before the trial drug is due to be given

Both Part I and Part II:

• People with clinically significant health conditions or medical history affecting the liver, kidneys, nervous system, immune system, lungs, digestive system, hormones, blood, heart and blood vessels, urinary system, or mental health (note: people aged 65 and over with mild health conditions may still be considered if the trial doctor determines they can safely stop relevant medications ahead of time)
• People with digestive conditions such as Crohn's disease, stomach ulcers, gastritis, gastric spasms, or gastroesophageal reflux disease, or who have had stomach or bowel surgery (other than a simple appendix removal or hernia repair) that could affect how the trial drug behaves in the body
• People who have had a significant allergic or hypersensitivity reaction to the trial drug's active ingredient (BnH-015B), drugs in the same class (NMDAR modulators), or certain other medications such as aspirin or antibiotics
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis in a blood test
• People with a history of alcohol or drug misuse, or who test positive for illicit drugs in a urine screening test
• People who show significant abnormalities in a neurological examination at screening
• People whose blood pressure readings (taken after sitting quietly for at least 3 minutes) fall outside the following ranges: systolic below 80 or above 139 mmHg, or diastolic below 45 or above 89 mmHg
• People whose heart rhythm trace (ECG) shows a QT/QTc interval above 450 milliseconds or other clinically significant abnormal findings
• People whose blood test results show liver enzyme levels (AST or ALT) more than 1.5 times the upper limit of normal, or kidney function (eGFR) below 60 mL/min/1.73m²
• People who have taken prescription medications or herbal medicines within 2 weeks, or any over-the-counter drugs, dietary supplements, or vitamins within 1 week, before the planned first dose (the trial doctor may still consider enrolment in some cases)
• People who have taken enzyme-affecting medications such as barbiturates or clarithromycin within 1 month before the planned first dose
• People who have participated in another clinical trial and received an investigational drug within 6 months before the planned first dose
• People who have donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 2 months before the planned first dose
• People who currently smoke, or who have not stopped smoking for at least 3 months before the planned first dose, or who cannot abstain from smoking for the entire study period
• People who regularly drink more than 21 units of alcohol per week (where 1 unit equals 10 g of pure alcohol), or who cannot avoid alcohol from 3 days before the first dose until the end of the study
• People who regularly consume more than 5 units of caffeine per day, or who cannot avoid caffeine-containing food and drinks (such as coffee, tea, soft drinks, energy drinks, and sports drinks) from 3 days before the first dose until the end of the study
• People who have consumed grapefruit, grapefruit juice, or grapefruit-containing products within 3 days before the planned first dose, or who cannot avoid these throughout the study period
• People with unusual dietary habits (such as drinking more than 1 litre of grapefruit juice daily) or who are unable to eat the standardised meals provided by the trial centre during inpatient stays
• People who, or whose spouse or partner, are unwilling or unable to use medically acceptable contraception throughout the study and for at least 3 months after the last dose, or who do not agree to avoid donating sperm or eggs during this time (the egg donation restriction applies to Part II only)
• People who have difficulty swallowing or who are unable to swallow multiple tablets or capsules
• People the trial doctor considers unsuitable for any other reason