Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160531
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Brief Title:
Influenza Viral Challenge Study of CC-42344 in Healthy Participants
Sponsor:
Cocrystal Pharma Inc
Organization:
Cocrystal Pharma Inc
Study Overview
Official Title:
Randomised Phase 2a Double-blind Placebo-controlled Study to Evaluate the Antiviral Activity Against Influenza Infection Safety Tolerability and Pharmacokinetics of CC-42344 Via a Human Viral Challenge Model in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Participants in this study will be given either CC-42344 one of two dose levels or placebo orally for 5 days after receiving an influenza flu challenge virus Participants will not know whether they are getting placebo or CC-42344 The amount of virus in nasal samples will be measured over time Side effects and pharmacokinetics the amount of CC-42344 in blood will also be measured
Detailed Description:
This is a single-center phase 2a randomized double-blind placebo-controlled study in healthy adult participants The primary goal of this study is to assess the antiviral activity of orally administered CC-42344 in an influenza human viral challenge model and to explore the impact of different dose levels on efficacy In addition the safety tolerability and pharmacokinetics will be assessed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPI-CST-001 | OTHER | hVIVO | None |