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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.
Details
| Lead sponsor | BnH Research |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 92 |
| Start date | 2024-10-22 |
| Completion | 2026-06 |
Conditions
- Alzheimer Disease
Interventions
- BnH-015B 5 mg
- BnH-015B 10 mg
- BnH-015B 20 mg
- BnH-015B 40 mg (Dietary impact)
- BnH-015B 40 mg
- BnH-015B 80 mg
- BnH-015B 160 mg
- BnH-015B 40 mg (MAD)
- BnH-015B 80 mg (MAD)
- BnH-015B 40 mg (Part II)
Primary outcomes
- Number of occurrences, affected participants with adverse events — Through study completion, an average of 14 days
Safety/tolerability evaluation - 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
Countries
South Korea