Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609460
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2b Randomized Double-blind Placebo-controlled Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388 a Novel Long-acting Antiviral Conjugate for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
Status:
RECRUITING
Status Verified Date:
2024-10
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:
NAVIGATE
Brief Summary:
The purpose of this study is to select a dose of CD388 that is effective in preventing symptomatic laboratory-confirmed influenza infections as compared to placebo when administered as a single dose via 3 subcutaneous SQ injections to adult participants in stable health and to evaluate the safety and tolerability of CD388 as compared to placebo
Detailed Description:
This is a Phase 2b randomized double-blind placebo-controlled parallel-group multicenter dose selection study to evaluate the efficacy safety and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza
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