Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis

Phase 2

Waitlist Available

Led By Mark Montgomery, MD

Research Sponsored by SolAeroMed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called S-1226 on patients with mild to moderate Cystic Fibrosis and non-CF bronchiectasis. The goal is to see if it can safely help clear mucus from their lungs and improve their breathing. Patients will receive different amounts to find the safest dose.

Eligible Conditions

Cystic Fibrosis
Bronchiectasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-emergent adverse events

Secondary study objectives

Change from baseline in percent of predicted forced expiratory volume in 1 Second

Cystic Fibrosis

Other study objectives

Change from baseline in Forced Expiratory Flow at 25-75%

Vital capacity

Change from baseline in Inspiratory Capacity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation StudyExperimental Treatment1 Intervention

Subjects will receive up to three inhaled doses of S- 1226. Each dose will be administered over a 2-minute treatment period (with a minimum 2-minute break between treatments) with a nebulizer as follows. Three S-1226 formulations will be tested sequentially: * S-1226(4%) is composed of 3 mL PFOB and 4% CO2 * S-1226(8%) is composed of 3 mL PFOB and 8% CO2 * S-1226(12%) is composed of 3 mL PFOB and 12% CO2 Each formulation will be administered by inhalation for a period of 2 minutes.The nebulizer will be filled with 3 mL of PFOB. The nebulizer is connected to a compressed medical gas mixture consisting of either 4%, 8% or 12%, CO2. A driving pressure of 20 psi will be used, producing a gas flow rate of 9 L/min.

Group II: Daily Dosing StudyExperimental Treatment1 Intervention

Eligible subjects will receive S-1226 twice daily for 5 consecutive days. Subjects will receive up to three doses of S-1226 in the morning and afternoon, administered over three 2-minute periods with a Circulaire nebulizer, filled with one of the dosages outlined below, depending on the safety and tolerability data gathered from the dose escalation study for that particular subject. * S-1226(4%) is composed of 3 mL PFOB and 4% CO2 * S-1226(8%) is composed of 3 mL PFOB and 8% CO2 * S-1226(12%) is composed of 3 mL PFOB and 12% CO2

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