Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486662
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients
Sponsor:
OM Pharma SA
Organization:
OM Pharma SA
Study Overview
Official Title:
Safety Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge
Status:
RECRUITING
Status Verified Date:
2024-06
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 study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
Detailed Description:
This study is a double-blind randomised placebo-controlled single and multiple ascending doses parallel group design study that aims to assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
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 |
|---|---|---|---|
| 2022-503053-19-00 | CTIS | None | None |