NCT06535308

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: BnH Research · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	BnH-015B 5 mg	Korean / 3 on BnH-015B, 1 on placebo
DRUG	BnH-015B 10 mg	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 20 mg	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 40 mg (Dietary impact)	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 40 mg	Caucasian / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 80 mg	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 160 mg	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 40 mg (MAD)	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 80 mg (MAD)	Korean / 6 on BnH-015B, 2 on placebo
DRUG	BnH-015B 40 mg (Part II)	Korean / 9 subjects
DRUG	BnH-015B 80 mg (Part II)	Korean / 9 subjects
DRUG	BnH-015B Placebo (Part II)	Korean / 6 subjects

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2024-08-02
• Last updated: 2025-01-07

Locations

1 site across 1 country: South Korea