AsthmaPhase 1NCT02616770
Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study in Healthy Subjects.
A Phase 1 study testing S1226 (4%), Saline (for 4%) and S1226(8%) in people with Asthma, run by SolAeroMed Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- S1226 (4%), Saline (for 4%) and S1226(8%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator;
- 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;
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- 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 ;
- simultaneous use of male condom, and for the female partner, female condom and spermicide ;
- Sterile female partners include post-menopausal women (absence of menses for 12 months prior to drug administration) or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at least 6 months prior to drug administration).
- Capable of consent.
- Subjects must have a normal lung function (FEV1 ≥ 80 % of predicted and FEV1/FVC > 70 %).
Who cannot join
- 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.
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- 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);
- a depot injection or an implant of any drug within 3 months prior to the first dosing.
- monoamine oxidase (MAO) inhibitors within 30 days prior to the first dosing.
- Donation of blood within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
- Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening.
- Breast-feeding subject.
- History of wheezing after exercise
- History of or previous medical diagnosis of asthma
About this study
Official title: 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
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.
Read the 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
- Being tested
- S1226 (4%), Saline (for 4%), S1226(8%), Saline (for 8%), S1226(12%)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1226 (4%)Drug
Also called Perflubron and Medical Gas containing 4% Carbon Dioxide
3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose.
Saline (for 4%)Drug
Also called Saline and Medical Air
3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
S1226(8%)Drug
Also called Perflubron and Medical Gas containing 8% Carbon Dioxide
3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose.
Saline (for 8%)Drug
Also called Saline and Medical Air
3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
S1226(12%)Drug
Also called Perflubron and Medical Gas containing 12% Carbon Dioxide
3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose.
Saline (for 12%)Drug
Also called Saline and Medical Air
3ml saline nebulized with Medical Air for 2 minutes as a single dose
| Study group | Role | What they receive |
|---|---|---|
| S1226 (4%) | Experimental | S1226 (4%) dosed as single dose for 2 minutes Receives: Drug: S1226 (4%) |
| Saline (for 4%) | Placebo comparator | 3 mL saline and medical air as single dose for 2 minutes Receives: Drug: Saline (for 4%) |
| S1226 (8%) | Experimental | S1226 (8%) dosed as single dose for 2 minutes Receives: Drug: S1226(8%) |
| Saline (for 8 %) | Placebo comparator | 3 mL saline and medical air as single dose for 2 minutes Receives: Drug: Saline (for 8%) |
| S1226 (12%) | Experimental | S1226 (12%) dosed as single dose for 2 minutes Receives: Drug: S1226(12%) |
| Saline (for 12%) | Placebo comparator | 3 mL saline and medical air as single dose Receives: Drug: Saline (for 12%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability to S-1226 assessment by evaluating adverse events, vital signs, 12-lead ECG, clinical laboratory parameters, and physical examination.
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SolAeroMed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Latifa Yamlahi, MSc, Study director, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616770
- Sponsor's protocol ID
- SAMi-01-1-01
- Status last verified
- Sep 2014
- First submitted
- 25 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27464582
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02616770
- Acronym / sponsor ID
- SAMi-01-1-01
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SolAeroMed Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| S1226 (4%) | Experimental | Drug: S1226 (4%)S1226 (4%) dosed as single dose for 2 minutes |
| Saline (for 4%) | Placebo comparator | Drug: Saline (for 4%)3 mL saline and medical air as single dose for 2 minutes |
| S1226 (8%) | Experimental | Drug: S1226(8%)S1226 (8%) dosed as single dose for 2 minutes |
| Saline (for 8 %) | Placebo comparator | Drug: Saline (for 8%)3 mL saline and medical air as single dose for 2 minutes |
| S1226 (12%) | Experimental | Drug: S1226(12%)S1226 (12%) dosed as single dose for 2 minutes |
| Saline (for 12%) | Placebo comparator | Drug: Saline (for 12%)3 mL saline and medical air as single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Male or female, non-smoker, ≥18 and ≤55 years of age with BMI > 18.5 and < 30.0.
- Healthy as defined by:
- 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:
- 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:
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1226 (4%)Also: Perflubron and Medical Gas containing 4% Carbon Dioxide3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose. | Drug | S1226 (4%) |
| Saline (for 4%)Also: Saline and Medical Air3ml saline nebulized, with Medical Air, for 2 minutes as a single dose | Drug | Saline (for 4%) |
| S1226(8%)Also: Perflubron and Medical Gas containing 8% Carbon Dioxide3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose. | Drug | S1226 (8%) |
| Saline (for 8%)Also: Saline and Medical Air3ml saline nebulized, with Medical Air, for 2 minutes as a single dose | Drug | Saline (for 8 %) |
| S1226(12%)Also: Perflubron and Medical Gas containing 12% Carbon Dioxide3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose. | Drug | S1226 (12%) |
| Saline (for 12%)Also: Saline and Medical Air3ml saline nebulized with Medical Air for 2 minutes as a single dose | Drug | Saline (for 12%) |
Primary outcome
Safety and tolerability to S-1226 assessment by evaluating adverse events, vital signs, 12-lead ECG, clinical laboratory parameters, and physical examination.
Time frame: 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Derived from this study: PubMed 27464582Green 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Latifa Yamlahi, MSc study director
Pharma Medica Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S1226 (4%), Saline (for 4%) and S1226(8%) in people with Asthma, run by SolAeroMed Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability to S-1226 assessment by evaluating adverse events, vital signs, 12-lead ECG, clinical laboratory parameters, and physical examination. (time frame: 24 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.