Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535308
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
BnH-015B Clinical Trial in Moderate Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Dose-block Randomized Double-blind Placebo-controlled Single and Multiple Dosing Dose-escalation Phase 1 Clinical Trial to Evaluate the SafetyTolerability 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 Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BDNFTRKβ and microglia-mediated IL-33OPN signaling pathways therefore it is expected to be a promising new drug that can significantly improve symptoms associated with Alzheimers disease including memory loss
Detailed Description:
Given that existing treatments for Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None