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

NCT02616770 | Completed Phase 1 DMC

• 1 other identifier: SAMi-01-1-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability to S-1226 assessment by evaluating adverse events, vital signs, 12-lead ECG, clinical laboratory parameters, and physical examination.

  24 hours post dose

Study Arms (6)

S1226 (4%)

EXPERIMENTAL

S1226 (4%) dosed as single dose for 2 minutes

Drug: S1226 (4%)

Saline (for 4%)

PLACEBO COMPARATOR

3 mL saline and medical air as single dose for 2 minutes

Drug: Saline (for 4%)

S1226 (8%)

EXPERIMENTAL

S1226 (8%) dosed as single dose for 2 minutes

Drug: S1226(8%)

Saline (for 8 %)

PLACEBO COMPARATOR

3 mL saline and medical air as single dose for 2 minutes

Drug: Saline (for 8%)

S1226 (12%)

EXPERIMENTAL

S1226 (12%) dosed as single dose for 2 minutes

Drug: S1226(12%)

Saline (for 12%)

PLACEBO COMPARATOR

3 mL saline and medical air as single dose

Drug: Saline (for 12%)

Interventions

S1226 (4%) DRUG

3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose.

Also known as: Perflubron and Medical Gas containing 4% Carbon Dioxide

S1226 (4%)

Saline (for 4%) DRUG

3ml saline nebulized, with Medical Air, for 2 minutes as a single dose

Also known as: Saline and Medical Air

Saline (for 4%)

S1226(8%) DRUG

3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose.

Also known as: Perflubron and Medical Gas containing 8% Carbon Dioxide

S1226 (8%)

Saline (for 8%) DRUG

3ml saline nebulized, with Medical Air, for 2 minutes as a single dose

Also known as: Saline and Medical Air

Saline (for 8 %)

S1226(12%) DRUG

3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose.

Also known as: Perflubron and Medical Gas containing 12% Carbon Dioxide

S1226 (12%)

Saline (for 12%) DRUG

3ml saline nebulized with Medical Air for 2 minutes as a single dose

Also known as: Saline and Medical Air

Saline (for 12%)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, non-smoker, ≥18 and ≤55 years of age with BMI \> 18.5 and \< 30.0.
• Healthy as defined by:
• the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease;
• the absence of clinically significant respiratory infection in the preceding 6 weeks;
• the absence of history of malignancy within the past five years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix;
• the absence of clinically significant findings on a chest X-Ray at screening.
• Steroid-naive (i.e. volunteers who are not currently on topical or systemic corticosteroids or those who have not taken any oral or injectable corticosteroid within 60 days prior to study drug administration or have not used any inhaled/ophthalmic/nasal corticosteroid within 30 days prior to study drug administration).
• Females of childbearing potential who are sexually active with male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after:
• simultaneous use of intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to study drug administration, and for the male partner, condom;
• simultaneous use of diaphragm and for the male partner, male condom and spermicide starting at least 14 days prior to study drug administration;
• simultaneous use of female condom starting at least 14 days prior to study drug administration, and for the male partner, condom and spermicide;
• sterile male partner (vasectomized since at least 6 months).
• Males subjects who are not vasectomized for more than 6 months, and who are sexually active with non-sterile female partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after:
• simultaneous use of condom, and for the female partner, oral contraceptive, or intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
• simultaneous use of male condom, and for the female partner, diaphragm and spermicide ;

You may not qualify if:

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
• Positive urine drug screen or urine cotinine test at screening.
• Current cigarette smokers or former smokers with a smoking history of greater than 5 pack years or who stopped smoking within the 2 years preceding enrolment in the study. For the determination of pack years, a pack of cigarettes is assumed to contain 20 cigarettes.
• History of significant allergic reactions (e.g. angioedema, anaphylactic reactions).
• History of panic disorder or panic attacks
• Positive pregnancy test at screening.
• Any reason which, in the opinion of the Investigator (or delegate), would prevent the subject from participating in the study.
• Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]) or positive alcohol breath test at screening.
• History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and crack) within 1 year prior to screening.
• Use of an investigational drug within 30 days (90 days for biologics) or participation in an investigational study within 30 days prior to dosing.
• Use of anticoagulants, immunosuppressives, regular use of non-steroidal anti-inflammatory drugs, use of anti-IgE medication, or any allergen specific immunotherapy within the last 60 days.
• Use of medication other than non-steroidal topical products without significant systemic absorption:
• prescription medication (other than the ones listed previously) within 14 days prior to the first dosing;
• over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);

Sponsors & Collaborators

• SolAeroMed Inc.: lead

Related Publications (1)

• Green FH, Leigh R, Fadayomi M, Lalli G, Chiu A, Shrestha G, ElShahat SG, Nelson DE, El Mays TY, Pieron CA, Dennis JH. A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers. Trials. 2016 Jul 28;17:361. doi: 10.1186/s13063-016-1489-8.

  PMID: 27464582 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

perfluorooctylbromide and CO2 drug combination; perflubron; Carbon Dioxide; Sodium Chloride; Air

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Latifa Yamlahi, MSc

  Pharma Medica Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 30, 2015

Record last verified: 2014-09