A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.

Official Title
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A Double-Blind, Randomized, 3 Period Crossover, Single Ascending Dose Study to Assess the Safety, and Tolerability of Inhaled MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma

Conditions
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Drug Safety

Intervention / Treatment
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* Drug: MDT-637
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented clinical history and physician diagnosis of intermittent or mild or moderate persistent asthma for at least 6 months prior to screening OR subjects with historical record of Beta-agonist reversibility within previous 5 years Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL. Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result Males and/or females (if not surgically sterile or confirmed to be post menopausal) must agree to practice 2 barrier contraception methods until they are discharged from the study Willing to give written informed consent 18 to 50 years of age BMI of 19-30 kg/m2 Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study Good general health (excepting asthma) as determined by medical history, physical examination, ECG and clinical laboratory tests Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to dosing and for 24 hours after dosing. Exclusion Criteria: Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator, Medical Monitor or Sponsor (MicroDose Therapeutx; MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637 Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC < 75% of predicted and/or FEV1/FVC ratio < 0.7) FEV1 variability > 12% between Visit 1 and Visit 2 Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis. Upper respiratory tract infection within 6 weeks of Visit 1 Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week History of significant nasal irritation from nasal inhalation of medication History of malignancy History of clinically significant alcohol or drug abuse Positive drug screen for drugs of abuse Positive test for HIV, Hepatitis B or Hepatitis C Allergy to lactose, or lactose intolerance Use of prescription medication (other than SAB and/or low dose inhaled corticosteroid e.g. fluticasone propionate 44 mcg BID or budesonide 100 mcg BID or equivalent) within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2 Positive urine pregnancy test at Visit 1 or Visit 2 or visit 4 Abnormal QTc interval at Visit 1(> 450 msec in males or > 470 msec in females) Significant blood donation (or testing) in previous 8 weeks Use of any Investigational Product in previous 6 weeks (small molecule products) or previous 3 months (biologic products)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: MDT-637<br> | Drug: MDT-637<br>* Inhaled doses of MDT-637 over a 24 hour period at 3 visits<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. | Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events. | Up to 61 days (including up to 42 days of screening period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetics for MDT-637 dry powder inhalation | Plasma Samples will be measured to determine MDT-637 pharmacokinetics | Multiple plasma samples collected, upto 24 hr post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus Infection, RSV