Acute Inflammatory Response to Non-antigenic StimulusPhase 1LPSNCT02515396
Phase 1a Study in Healthy Smokers to Investigate the Effect With MMI-0100 on Airway Inflammation in Induced Sputum After Challenge With Inhaled Lipopolysaccharide
A Phase 1 study testing MMI-0100 in people with Acute Inflammatory Response to Non-antigenic Stimulus, run by Moerae Matrix, Inc. at 1 site in United Kingdom.
Trial summary
A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory markers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Inflammatory Response to Non-antigenic Stimulus
- What is being tested?
- MMI-0100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jun 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written signed informed consent
- Comply with study procedures
- Body mass index (BMI) between 18 and 35 kg/m2 inclusive;minimum body weight of 50 kg
- Male subjects:
- Subjects with female partners of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected or hormonal methods of contraception or intrauterine device/system by the female partner, in combination with a barrier method (e.g. condom, diaphragm, cervical cap with spermicide) during the study and for 3 months after discontinuation of treatment
- Subjects who are sterilised or have a female partner who is sterilised
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- Subjects with a lifestyle that implies abstinence from sexual activity during the study and for 3 months after discontinuation of treatment
- Female subjects:
- Confirmed post-menopausal women (no periods for at least one year and follicle stimulating hormone (FSH) levels compliant with post-menopausal status according to reference values)
- Subjects agreeing to use highly effective form of birth control, which entails the use of oral, injected or implanted hormonal methods of contraception or intrauterine device/system in combination with a barrier method (e.g. condom, diaphragm, cervical cap with spermicide) during the study and for 3 months after discontinuation of treatment
- For females of childbearing potential: females must have a negative urine pregnancy test at screening and admission
- Normal physical examination, laboratory values, 12-lead electrocardiogram (ECG) and vital signs
- Be current smokers with defined smoking history of ≥10 pack years
- Ability to perform reproducible spirometry
- Demonstrate an FEV1 ≥80% of their predicted normal
- Demonstrate no evidence of airway obstruction
- Normal airway responsiveness to inhaled methacholine
- Have negative screens for serum hepatitis B surface antigen, Hepatitis C antigen and human immunodeficiency virus (HIV)
- Be able to produce a minimum of 0.1g sputum after induction with inhaled hypertonic saline at Visit 0
Who cannot join
- Subjects with an uncontrolled cardiovascular, respiratory, haematologic, immunologic, renal, neurologic, hepatic, endocrine disease, or any condition that might, in the judgment of the Investigator, place the subject at undue risk or potentially compromise the results or interpretation of the study
- Any clinically relevant abnormal value or physical finding that may interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study
- Symptoms, signs or laboratory findings suggestive of an ongoing infective illness at the time of enrolment
- A history of respiratory disease including asthma
- Donation of more than 1200 mL of blood within 12 months of Visit 0 or, donation of blood in total >500 mL within 3 months prior to Visit 0
- Symptoms of any clinically significant illness within 2 weeks pior to Visit 0
- A significant history of alcohol abuse or consumption of more than 28 units (male) or 21 units (female) of alcohol per week
- A significant history of drug abuse (including benzodiazepines) or positive urine drugs of abuse test
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Clinical Trials, The Heart Lung Centre
London, England, W1G 8HU
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover Study in Healthy Smokers to Investigate the Effect of Inhaled Dosing With MMI-0100 on Airway Inflammation as Assessed in Induced Sputum After Challenge With Inhaled Lipopolysaccharide (LPS)
A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory markers.
Read the detailed description
The purpose of this Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo on inflammatory markers following 5 days once daily (qd) dose of MMI-0100 or placebo administered by inhalation. On Day 5 of each treatment period, subjects will be challenged with inhaled LPS. Pharmacokinetics and biomarkers will be conducted at selected timepoints.
- Being tested
- MMI-0100, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMI-0100Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | MMI-0100 Inhaled, once daily x 5, followed by 3 week washout period, followed by Placebo Inhaled, once daily x 5 Receives: Drug: MMI-0100; Drug: Placebo |
| Treatment Group B | Experimental | Placebo Inhaled, once daily x 5, followed by 3 week washout period, followed by MMI-0100 Inhaled, once daily x 5 Receives: Drug: MMI-0100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 6 weeks
Cytokine Biomarkers
Measured: 6 weeks
Secondary outcomes (1)
Neutrophil cell counts in sputum following LPS challenge
Measured: Within 1 day following challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Inflammatory Response to Non-antigenic StimulusStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moerae Matrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515396
- Sponsor's protocol ID
- MMI-0100 RCT205
- Acronym
- LPS
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover Study in Healthy Smokers to Investigate the Effect of Inhaled Dosing With MMI-0100 on Airway Inflammation as Assessed in Induced Sputum After Challenge With Inhaled Lipopolysaccharide (LPS)
- ClinicalTrials.gov ID
- NCT02515396
- Acronym / sponsor ID
- LPS / MMI-0100 RCT205
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moerae Matrix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 4 Aug 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.
A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory markers.
Detailed description
The purpose of this Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo on inflammatory markers following 5 days once daily (qd) dose of MMI-0100 or placebo administered by inhalation. On Day 5 of each treatment period, subjects will be challenged with inhaled LPS. Pharmacokinetics and biomarkers will be conducted at selected timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: MMI-0100, Drug: PlaceboMMI-0100 Inhaled, once daily x 5, followed by 3 week washout period, followed by Placebo Inhaled, once daily x 5 |
| Treatment Group B | Experimental | Drug: MMI-0100, Drug: PlaceboPlacebo Inhaled, once daily x 5, followed by 3 week washout period, followed by MMI-0100 Inhaled, once daily x 5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written signed informed consent
- Comply with study procedures
- Body mass index (BMI) between 18 and 35 kg/m2 inclusive;minimum body weight of 50 kg
- Male subjects:
- Female subjects:
Key exclusion criteria (8 listed)
- Subjects with an uncontrolled cardiovascular, respiratory, haematologic, immunologic, renal, neurologic, hepatic, endocrine disease, or any condition that might, in the judgment of the Investigator, place the subject at undue risk or potentially compromise the results or interpretation of the study
- Any clinically relevant abnormal value or physical finding that may interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study
- Symptoms, signs or laboratory findings suggestive of an ongoing infective illness at the time of enrolment
- A history of respiratory disease including asthma
- Donation of more than 1200 mL of blood within 12 months of Visit 0 or, donation of blood in total >500 mL within 3 months prior to Visit 0
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 |
|---|---|---|
| MMI-0100 | Drug | Treatment Group A, Treatment Group B |
| Placebo | Drug | Treatment Group A, Treatment Group B |
Primary outcome
Adverse Events
Time frame: 6 weeks
Cytokine Biomarkers
Time frame: 6 weeks
1 secondary outcome
Neutrophil cell counts in sputum following LPS challenge
Time frame: Within 1 day following challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MMI-0100 in people with Acute Inflammatory Response to Non-antigenic Stimulus, run by Moerae Matrix, Inc. at 1 site in United Kingdom.
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 19 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Adverse Events (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2017.