Single-centre clinical trial investigating safety and tolerability of repeated administrations of increasing doses of nebulised SS0331 in healthy participants followed by an investigation of the preliminary effect of nebulised SS0331 in participants with chronic airway infections

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Softox Solutions AS

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

17 Feb 2026 → ongoing

Decision date (initial)

2025-12-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of this PoC trial is to investigate the preliminary efficacy, defined as a reduction in the sputum density of bacteria (CFU/g), of inhaled nebulised SS0331 administered TID for five days in chronically airway-infected CF/PCD)/NCFB patients.

Secondary objectives 1

1. The secondary objective of the current trial is to assess the safety and tolerability of multiple ascending doses of nebulised SS0331 in healthy participants in the dose-escalation part of the trial in order to select a well-tolerated dose to be tested CF/PCD/NCFB patients in the PoC part of the trial.

Conditions and MedDRA coding

Chronic airway infections

Regulatory references

Scientific advice from competent authorities

Danish Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Phase 1: Participants are eligible to participate in the dose-escalation part of the trial if they are healthy, between 18 and 55 years of age, and have a Body Mass Index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
2. Phase 2a: Adult CF/PCD/NCFB patients with chronic airway infection are eligible to participate in the PoC part of the trial if their underlying CF/PCD/NCFB disease is stable and they are able to spontaneously expectorate >1 g sputum with a bacterial density of at least 5 log10 colony-forming units (CFU) per g

Exclusion criteria 2

1. Phase 1: Participants are not eligible to participate in the dose-escalation part of the trial if they have recently participated in another clinical trial or have donated blood; are pregnant or lactating; have a medical condition or a history of drug hypersensitivity; are using concomitant medication.
2. Phase 2a: CF/PCD/NCFB patients are not eligible to participate in the PoC part of the trial if their forced expiratory volume (FEV1) is below 30% of predicted or their oxygen saturation is below 90% determined by pulse oximetry; if they have recently participated in another clinical trial or have donated blood; are pregnant or lactating; have a medical condition other than their underlying CF/PCD/NCFB disease which in the opinion of the investigator precludes participation in the trial; have a history of drug hypersensitivity.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 1: The primary endpoint in the dose-escalation part of the trial is the nature, incidence, and severity of adverse events (AEs)
2. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Softox Solutions AS

Sponsor organisation

Softox Solutions AS

Address

Martin Linges Vei 25

City

Fornebu

Postcode

1364

Country

Norway

Scientific contact point

Organisation

Softox Solutions AS

Contact name

CEO/CSO

Public contact point

Organisation

Softox Solutions AS

Contact name

CEO/CSO

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications