Clinical trial • Phase I • Infectious Disease
SS0331 (nebulised) for Respiratory tract infection | Biologic countermeasure
Phase I trial of SS0331 (nebulised) for Respiratory tract infection | Biologic countermeasure. 48 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Respiratory tract infection | Biologic countermeasure
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-10-2025
- First CTIS Authorization Date
- 20-02-2026
Trial design
Phase I trial across 1 site in Ireland.
- Target Sample Size
- 48
Eligibility
Recruits 48 No vulnerable population selected; trial population: Healthy volunteers. Consent/assent handling not specified..
- Vulnerable Population
- No vulnerable population selected; trial population: Healthy volunteers. Consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 48
Ireland
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 48
Sites
- Site Name
- University Hospital Galway
- Department Name
- Dept of Respiratory Medicine
- Contact Person Name
- Melissa McDonnell
- Contact Person Email
- Melissaj.mcdonnell@hse.ie
- Number Of Participants
- 48
Sponsor
Primary sponsor
- Full Name
- Softox Defense Solutions AS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- SS0331 (nebulised)
- Routes Of Administration
- Nebulised (inhalation)
- Route
- Inhalation
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