NCT02616770

Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study in Healthy Subjects.

Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study to Evaluate the Safety and Tolerability of S-1226 Administered by Nebulization in Normal Health Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: SolAeroMed Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of S-1226 composed of perflubron with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered over 2 minute nebulisation to healthy subjects.

Detailed description

There will be up to 3 cohorts (1 cohort per dose level). Each cohort will include 12 subjects (9 receiving S-1226 and 3 receiving matching placebo). For each dose level, a sentinel group of 2 subjects will be dosed (1 subject with S-1226, 1 subject with placebo) 24 hours prior to dosing the rest of the study population. It may be necessary to repeat, or modify (decrease) a dose level, and thus an additional cohort of up to 12 subjects may be enrolled.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	S1226 (4%)	3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose.
DRUG	Saline (for 4%)	3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
DRUG	S1226(8%)	3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose.
DRUG	Saline (for 8%)	3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
DRUG	S1226(12%)	3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose.
DRUG	Saline (for 12%)	3ml saline nebulized with Medical Air for 2 minutes as a single dose

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2015-11-30
• Last updated: 2015-11-30