Open-labelled, single-centre investigation of safety and tolerability of multiple ascending doses of nebulised SS0331 in healthy participants followed by investigation of preliminary efficacy of nebulised SS0331 in airway-infected patients with chronic airway infections

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523875-48-00

Acronym

SIS-03

Enrollment

Registered

2025-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic airway infections

Brief summary

Phase 1: The primary endpoint in the dose-escalation part of the trial is the nature, incidence, and severity of adverse events (AEs), Phase 2a: The primary endpoint in the PoC part of the trial is the change from baseline in log10-transformed sputum density of bacteria following treatment

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Phase 1: The primary endpoint in the dose-escalation part of the trial is the nature, incidence, and severity of adverse events (AEs), Phase 2a: The primary endpoint in the PoC part of the trial is the change from baseline in log10-transformed sputum density of bacteria following treatment	—

Countries

Denmark

Outcome results