NCT06999603

Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

A Phase 2, Two-part Study to Assess the Safety, Antiviral Biomarker Responses, and Efficacy of Inhaled SNG001 for the Treatment of Patients With a Confirmed Respiratory Virus Infection Undergoing Invasive Mechanical Ventilation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Synairgen Research Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase 2 study is to assess about the safety, antiviral biomarker responses and efficacy of SNG001 when given to patients requiring invasive mechanical ventilation due to a respiratory virus infection. Its ability to speed up virus clearance and reduce mortality, compared with standard of care, will be studied. The study is split into two parts. All participants will receive standard of care in addition to SNG001 or placebo. In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older will receive study drug or placebo once a day for up to 14 days, whilst in hospital. In Part 2, the primary objective will be the efficacy of SNG001. Participants between 18 and 50 years with an immunocompromising condition and patients over 50 years (with or without an immunocompromising condition) will receive study drug once a day for up to 14 days, whilst in hospital.

Conditions

• Viral Pneumonia

Interventions

Type	Name	Description
DRUG	SNG001	SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ 1a.
DRUG	Placebo	The placebo nebuliser solution is presented in glass syringes containing 0.65 mL of solution containing the same formulation as the study medication but without IFNβ 1a (i.e., only the excipients of the SNG001 solution).

Timeline

• Start date: 2025-09-02
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2025-05-31
• Last updated: 2025-12-31

Locations

67 sites across 6 countries: United States, Belgium, France, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study