Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500442
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
A Study to Assess NEU-111 in Healthy Participants
Sponsor:
Neuron23 Inc
Organization:
Neuron23 Inc
Study Overview
Official Title:
A Phase 1 Study of NEU-111 Administered Orally to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 randomized double-blind placebo-controlled single ascending dose SAD multiple ascending dose MAD of orally administered NEU-111 in healthy subjects
Detailed Description:
Up to five 5 single-ascending oral doses will be administered to 40 healthy adult male or female subjects aged 18-64 years inclusive Escalation to the next higher dose level may occur only after evaluation of the safety and available PK results of the previous dose level at least 6 evaluable subjects Within each cohort 6 subjects will receive one dose of NEU-111 and 2 subjects will receive one dose of matching placebo Dose levels may be revised based upon available safety and PK data
Multiple ascending oral doses will be administered up to 24 healthy subjects aged 18-64 years inclusive in 3 sequential dosing groups 8 subjects in each dosing group Six 6 subjects will receive NEU-111 and two 2 subjects will receive matching placebo in each dosing group cohort for 10 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 upon available safety and PK data
Multiple ascending oral doses will be administered up to 24 healthy subjects aged 18-64 years inclusive in 3 sequential dosing groups 8 subjects in each dosing group Six 6 subjects will receive NEU-111 and two 2 subjects will receive matching placebo in each dosing group cohort for 10 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 upon available safety and PK data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None