NCT06535308

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline
1mo left

Started Oct 2024

Typical duration for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

July 8, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 22, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

July 8, 2024

Last Update Submit

January 6, 2025

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • Number of occurrences, affected participants with adverse events

    Safety/tolerability evaluation

    Through study completion, an average of 14 days

  • Pharmacokinetic (PK) plasma concentration of BnH-015B

    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)

  • Changes in serum biomarker concentration

    Baseline and 14 days after administration

Other Outcomes (1)

  • Changes in the metabolites of BnH-015B

    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

Study Arms (12)

BnH-015B 5 mg

EXPERIMENTAL

Cohort 1 / Single-dose

Drug: BnH-015B 5 mg

BnH-015B 10 mg

EXPERIMENTAL

Cohort 2 / Single-dose

Drug: BnH-015B 10 mg

BnH-015B 20 mg

EXPERIMENTAL

Cohort 3 / Single-dose

Drug: BnH-015B 20 mg

BnH-015B 40 mg (Dietary impact)

EXPERIMENTAL

Cohort 4 / Single-dose

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

BnH-015B 40 mg

EXPERIMENTAL

Cohort 4-1 / Single-dose

Drug: BnH-015B 40 mg

BnH-015B 80 mg

EXPERIMENTAL

Cohort 5 / Single-dose

Drug: BnH-015B 80 mg

BnH-015B 160 mg

EXPERIMENTAL

Cohort 6 / Single-dose

Drug: BnH-015B 160 mg

BnH-015B 40 mg (MAD)

EXPERIMENTAL

Cohort 7 / Multiple-dose

Drug: BnH-015B 40 mg (MAD)

BnH-015B 80 mg (MAD)

EXPERIMENTAL

Cohort 8 / Multiple-dose

Drug: BnH-015B 80 mg (MAD)

BnH-015B 40 mg (Part II)

EXPERIMENTAL

Experimental group 1

Drug: BnH-015B 40 mg (Part II)

BnH-015B 80 mg (Part II)

EXPERIMENTAL

Experimental group 2

Drug: BnH-015B 80 mg (Part II)

BnH-015B Placebo (Part II)

PLACEBO COMPARATOR

Placebo group

Drug: BnH-015B Placebo (Part II)

Interventions

BnH-015B 5 mgDRUG

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

BnH-015B 5 mg
BnH-015B 10 mgDRUG

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

BnH-015B 10 mg
BnH-015B 20 mgDRUG

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

BnH-015B 20 mg
BnH-015B 40 mg (Dietary impact)DRUG

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

BnH-015B 40 mg (Dietary impact)
BnH-015B 40 mgDRUG

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

BnH-015B 40 mg
BnH-015B 80 mgDRUG

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

BnH-015B 80 mg
BnH-015B 160 mgDRUG

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

BnH-015B 160 mg
BnH-015B 40 mg (MAD)DRUG

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

BnH-015B 40 mg (MAD)
BnH-015B 80 mg (MAD)DRUG

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

BnH-015B 80 mg (MAD)
BnH-015B 40 mg (Part II)DRUG

Korean / 9 subjects

BnH-015B 40 mg (Part II)
BnH-015B 80 mg (Part II)DRUG

Korean / 9 subjects

BnH-015B 80 mg (Part II)
BnH-015B Placebo (Part II)DRUG

Korean / 6 subjects

BnH-015B Placebo (Part II)

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \[Part I\] 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

You may not qualify if:

  • \[Part II\] 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Woosik Kim

CONTACT

(82-70)4366-4987obmouse@bnhresearch.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

August 2, 2024

Study Start

October 22, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

KR(1)