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

January 6, 2025 updated by: BnH Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • In Jin Jang, PI
          • Phone Number: 02-2072-1666
          • Email: irb@snuh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • [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
  • [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

Exclusion Criteria:

  • [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
  • [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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BnH-015B 5 mg
Cohort 1 / Single-dose
Drug: BnH-015B 5 mg
Korean / 3 on BnH-015B, 1 on placebo
Experimental: BnH-015B 10 mg
Cohort 2 / Single-dose
Drug: BnH-015B 10 mg
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 20 mg
Cohort 3 / Single-dose
Drug: BnH-015B 20 mg
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 40 mg (Dietary impact)
Cohort 4 / Single-dose
Drug: BnH-015B 40 mg (Dietary impact)
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 40 mg
Cohort 4-1 / Single-dose
Drug: BnH-015B 40 mg
Caucasian / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 80 mg
Cohort 5 / Single-dose
Drug: BnH-015B 80 mg
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 160 mg
Cohort 6 / Single-dose
Drug: BnH-015B 160 mg
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 40 mg (MAD)
Cohort 7 / Multiple-dose
Drug: BnH-015B 40 mg (MAD)
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 80 mg (MAD)
Cohort 8 / Multiple-dose
Drug: BnH-015B 80 mg (MAD)
Korean / 6 on BnH-015B, 2 on placebo
Experimental: BnH-015B 40 mg (Part II)
Experimental group 1
Drug: BnH-015B 40 mg (Part II)
Korean / 9 subjects
Experimental: BnH-015B 80 mg (Part II)
Experimental group 2
Drug: BnH-015B 80 mg (Part II)
Korean / 9 subjects
Placebo Comparator: BnH-015B Placebo (Part II)
Placebo group
Drug: BnH-015B Placebo (Part II)
Korean / 6 subjects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of occurrences, affected participants with adverse events
Time Frame: Through study completion, an average of 14 days
Safety/tolerability evaluation
Through study completion, an average of 14 days
Pharmacokinetic (PK) plasma concentration of BnH-015B
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in serum biomarker concentration
Time Frame: Baseline and 14 days after administration
Baseline and 14 days after administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Changes in the metabolites of BnH-015B
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BnH Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24_BnH-015B_P1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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