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

NCT02616770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-11-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • SolAeroMed Inc.

    lead INDUSTRY

Principal Investigators

  • Latifa Yamlahi, MSc · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616770 on ClinicalTrials.gov