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Alzheimer DiseasePhase 1NCT06535308

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

A Phase 1 study testing BnH-015B 5 mg, BnH-015B 10 mg and BnH-015B 20 mg in people with Alzheimer Disease, run by BnH Research at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
BnH-015B 5 mg, BnH-015B 10 mg and BnH-015B 20 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteSouth Korea
Study dates
22 Oct 2024to Jun 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • [Part I] Young adults: Healthy Korean or Caucasian male volunteers aged between 19 and 45 at the time of screening
  • [Part II] Individuals aged between 55 and 85 years at the time of informed consent
  • [Part II] The subject must be diagnosed with probable AD dementia according to the National Institute of Aging and Alzheimer Association (NIA-AA) diagnostic guidelines and must meet all of the following clinical criteria: MMSE score: 10-19, CDR-Global Score: 2
  • [Part II] Patients who are positive for P-tau181 and osteopontin in serum at the time of screening and are confirmed as amyloid positive via amyloid PET
  • [Part II] Patients diagnosed within the last 5 years prior to screening
  • [Part II] The subject (or the subject's legal representative) and caregiver must sign the consent for participation in the study, and the same caregiver must assist the subject throughout the entire study period and be continuously available for contact
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  • [Part II] Individuals who possess sufficient vision, hearing, language ability, motor function, and comprehension to follow the test procedures in the investigator's judgment
  • [Part I\&II] Individuals who weigh between 55.0 kg and 90.0 kg and have a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 at the time of the screening
  • [Part I\&II] Individuals who have received a full explanation about this clinical trial, completely understand it, and voluntarily decide to participate and agree in writing to follow the instructions (however, for Part II, consent from a guardian can be substituted for this)
  • [Part I\&II] Individuals deemed suitable as subjects for this study by the investigator based on physical examinations, clinical laboratory tests, and medical history evaluations

Who cannot join

  • [Part II] Patients with a history of unstable angina, myocardial infarction, progressive chronic heart failure (New York Heart Association class III or IV), or clinically significant electrocardiographic abnormalities within the year prior to screening
  • [Part II] Patients with a history of vascular dementia
  • [Part II] Patients diagnosed with dementia or cognitive impairment not related to Alzheimer's disease, including but not limited to significant head trauma, alcohol abuse, frontotemporal dementia, Huntington's disease, Parkinsonian syndromes (e.g., Parkinson's disease, Lewy body dementia), significant cerebrovascular disease, and/or significant seizure disorders
  • [Part II] Patients with psychotic symptoms primarily due to conditions other than Alzheimer's disease causing dementia (e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorders with psychotic symptoms)
  • [Part II] Patients who must take contraindicated medications throughout the entire study period
  • [Part II] Patients who have used cognitive-impairing, long-term permissible concomitant medications (e.g., antidepressants, anticonvulsants, atypical and typical antipsychotics, benzodiazepines) in unstable doses for at least 8 weeks prior to screening visit and during the screening period
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  • [Part II] Patients who have been vaccinated (including COVID-19 vaccines and booster shots) within 5 days prior to the administration of the investigational product
  • [Part I\&II] Individuals with clinically significant diseases or medical history in systems such as hepatobiliary, renal, neurological, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular, urogenital, or psychiatric systems (however, elderly individuals aged 65 and over who have mild medical histories may participate if the investigator determines that they can discontinue medication at least 2 weeks or five half-lives prior to the first expected administration date.)
  • [Part I\&II] Individuals with gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastric spasms, and gastroesophageal reflux disease) or a history of surgery (except for simple appendectomies or hernia surgeries) that may affect the safety/tolerability and pharmacokinetic evaluations of the investigational product
  • [Part I\&II] Individuals who have hypersensitivity reactions or have a clinically significant history of hypersensitivity reactions to drugs that contain the ingredient of the investigational product (BnH-015B) and those in the same class (NMDAR modulator) and other medications (such as aspirin and antibiotics)
  • [Part I\&II] Individuals with positive results in serum tests (hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis)
  • [Part I\&II] Individuals with a history of alcohol or drug abuse, or positive results for abused drugs in a urine drug screening test
  • [Part I\&II] Individuals who exhibit significant abnormalities in neurological examinations conducted at the time of screening
  • [Part I\&II] Individuals who show the following vital sign values when measured in a seated position after at least 3 minutes of rest: Systolic blood pressure < 80 mmHg or > 139 mmHg, Diastolic blood pressure < 45 mmHg or > 89 mmHg
  • [Part I\&II] Individuals who exhibit a QT/QTc interval > 450 msec or clinically significant abnormal rhythm findings on an electrocardiogram during screening
  • [Part I\&II] Individuals who show one or more of the following results in clinical laboratory tests during screening including additional tests: Blood levels of AST (SGOT), ALT (SGPT) > 1.5 times the upper limit of the normal range, eGFR calculated using the CKD-EPI equation: < 60 mL/min/1.73m2
  • [Part I\&II] Individuals who have taken any prescription drugs or herbal medicine within 2 weeks prior to the planned administration date of the investigational product, or any over-the-counter (OTC) drugs, dietary supplements including liver function aids, or vitamin preparations within 1 week (however, the investigator may choose to enroll the subject if other conditions are deemed appropriate), or are expected to take such substances
  • [Part I\&II] Individuals who have taken enzyme-inducing drugs like barbiturates or enzyme-inhibiting drugs like clarithromycin within 1 month prior to the planned administration date of the investigational product
  • [Part I\&II] Individuals who have participated in another clinical trial (including bioequivalence studies) and received an investigational product within 6 months prior to the planned administration date of the investigational product
  • [Part I\&II] Individuals who have donated whole blood within 2 months or components of blood within 1 month or received a blood transfusion within 2 months prior to the planned administration date of the investigational product
  • [Part I\&II] Current smokers (however, those who quit smoking at least 3 months prior to the planned administration date of the investigational product can be enrolled as subjects) or individuals who cannot abstain from smoking during the entire study period
  • [Part I\&II] Individuals who regularly consume alcohol (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol from 3 days prior to the first expected administration date until the end of the study
  • [Part I\&II] Individuals who have regularly consumed excessive caffeine (exceeding 5 units/day) or cannot abstain from consuming caffeine-containing foods and beverages (such as coffee, tea (black, green, etc.), carbonated drinks, coffee milk, energy drinks, and sports drinks) from 3 days prior to the planned administration date of the investigational product until the end of the study
  • [Part I\&II] Individuals who have consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the planned administration date of the investigational product until the end of the study, or cannot abstain from consuming such grapefruit-containing foods during this period
  • [Part I\&II] Individuals with unusual dietary habits (e.g., drinking more than 1 liter of grapefruit juice per day) or who cannot consume the standardized diet provided by the clinical trial center during the hospitalization period
  • [Part I\&II] Individuals who, or whose spouses (or partners), are unable or unwilling to use medically acceptable contraceptive methods during the entire study period and for at least 3 months after the last administration of the investigational product, or do not agree to refrain from donating sperm or eggs (applicable only to Part II) during this period
  • [Part I\&II] Individuals with dysphagia or who are unable to swallow multiple pills
  • [Part I\&II] Individuals deemed unsuitable for participation by the investigator for any other reason not specified above

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Woosik Kim contact

(82-70)4366-4987

obmouse@bnhresearch.co.kr

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

    In Jin Jang, PI, 02-2072-1666, irb@snuh.org

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed description

Given that existing treatments for Alzheimer's disease only temporarily alleviate symptoms or delay cognitive decline, there is an urgent need for new therapeutic options. Based on the aforementioned safety and efficacy study results, BnH Research Co., Ltd. intends to conduct this phase 1 clinical trial as the first-in-human study of BnH-015B to evaluate its safety and tolerability.

Being tested
BnH-015B 5 mg, BnH-015B 10 mg, BnH-015B 20 mg, BnH-015B 40 mg (Dietary impact), BnH-015B 40 mg
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BnH-015B 5 mgDrug

    Korean / 3 on BnH-015B, 1 on placebo

  • BnH-015B 10 mgDrug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 20 mgDrug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 40 mg (Dietary impact)Drug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 40 mgDrug

    Caucasian / 6 on BnH-015B, 2 on placebo

  • BnH-015B 80 mgDrug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 160 mgDrug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 40 mg (MAD)Drug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 80 mg (MAD)Drug

    Korean / 6 on BnH-015B, 2 on placebo

  • BnH-015B 40 mg (Part II)Drug

    Korean / 9 subjects

  • BnH-015B 80 mg (Part II)Drug

    Korean / 9 subjects

  • BnH-015B Placebo (Part II)Drug

    Korean / 6 subjects

Study groups in NCT06535308
Study groupRoleWhat they receive
BnH-015B 5 mgExperimentalCohort 1 / Single-dose
Receives: Drug: BnH-015B 5 mg
BnH-015B 10 mgExperimentalCohort 2 / Single-dose
Receives: Drug: BnH-015B 10 mg
BnH-015B 20 mgExperimentalCohort 3 / Single-dose
Receives: Drug: BnH-015B 20 mg
BnH-015B 40 mg (Dietary impact)ExperimentalCohort 4 / Single-dose
Receives: Drug: BnH-015B 40 mg (Dietary impact)
BnH-015B 40 mgExperimentalCohort 4-1 / Single-dose
Receives: Drug: BnH-015B 40 mg
BnH-015B 80 mgExperimentalCohort 5 / Single-dose
Receives: Drug: BnH-015B 80 mg
BnH-015B 160 mgExperimentalCohort 6 / Single-dose
Receives: Drug: BnH-015B 160 mg
BnH-015B 40 mg (MAD)ExperimentalCohort 7 / Multiple-dose
Receives: Drug: BnH-015B 40 mg (MAD)
BnH-015B 80 mg (MAD)ExperimentalCohort 8 / Multiple-dose
Receives: Drug: BnH-015B 80 mg (MAD)
BnH-015B 40 mg (Part II)ExperimentalExperimental group 1
Receives: Drug: BnH-015B 40 mg (Part II)
BnH-015B 80 mg (Part II)ExperimentalExperimental group 2
Receives: Drug: BnH-015B 80 mg (Part II)
BnH-015B Placebo (Part II)Placebo comparatorPlacebo group
Receives: Drug: BnH-015B Placebo (Part II)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of occurrences, affected participants with adverse events

    Safety/tolerability evaluation

    Measured: Through study completion, an average of 14 days

  2. Pharmacokinetic (PK) plasma concentration of BnH-015B

    Measured: 0 hours(pre-dose), 15 minutes, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post-dose

Secondary outcomes (1)

  1. Changes in serum biomarker concentration

    Measured: Baseline and 14 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start22 Oct 2024
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will proceed sequentially from Cohort 1 through 8, and the decision to proceed to the next dosage level will be determined by the Safety Review Committee (SRC) based on the safety and tolerability results of the previous dose stage
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535308
Sponsor's protocol ID
24_BnH-015B_P1
Status last verified
Jan 2025
First submitted
8 Jul 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BnH-015B 5 mg, BnH-015B 10 mg and BnH-015B 20 mg in people with Alzheimer Disease, run by BnH Research at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Woosik Kim ((82-70)4366-4987, obmouse@bnhresearch.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of occurrences, affected participants with adverse events (time frame: Through study completion, an average of 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06535308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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