Healthy Clinical Trial - A Study to Assess NEU-723 in Healthy Participants

Status Terminated

Clinical Trial Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), of orally administered NEU-723 in healthy subjects.

Clinical Trial Description

Up to five (5) single-ascending oral doses will be administered to 40 healthy adult male or female subjects (aged 18-80 years, inclusive). Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Within each cohort, 6 subjects will receive one dose of NEU-723, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based on available safety and PK data. Multiple ascending oral doses will be administered up to 24 healthy subjects (aged 18 - 80 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-723 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 7 days. Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Dose levels may be revised based on available safety and PD data. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05633745
Study type	Interventional
Source	Neuron23 Inc.
Contact
Status	Terminated
Phase	Phase 1
Start date	January 30, 2023
Completion date	June 30, 2023

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