A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Experimental: MDT-637
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Drug: MDT-637
Inhaled doses of MDT-637 over a 24 hour period at 3 visits
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Placebo Comparator: Placebo
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Drug: Placebo
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Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. [Up to 61 days (including up to 42 days of screening period)]
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
Secondary Outcome Measures
- Plasma pharmacokinetics for MDT-637 dry powder inhalation [Multiple plasma samples collected, upto 24 hr post last dose]
Plasma Samples will be measured to determine MDT-637 pharmacokinetics
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL.
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Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result
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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
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Willing to give written informed consent
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18 to 50 years of age
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BMI of 19-30 kg/m2
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Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
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Good general health (excepting asthma) as determined by medical history, physical examination, ECG and clinical laboratory tests
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Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to dosing and for 24 hours after dosing.
Exclusion Criteria:
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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
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Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
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Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC < 75% of predicted and/or FEV1/FVC ratio < 0.7)
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FEV1 variability > 12% between Visit 1 and Visit 2
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Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis.
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Upper respiratory tract infection within 6 weeks of Visit 1
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Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week
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History of significant nasal irritation from nasal inhalation of medication
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History of malignancy
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History of clinically significant alcohol or drug abuse
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Positive drug screen for drugs of abuse
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Positive test for HIV, Hepatitis B or Hepatitis C
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Allergy to lactose, or lactose intolerance
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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
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Positive urine pregnancy test at Visit 1 or Visit 2 or visit 4
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Abnormal QTc interval at Visit 1(> 450 msec in males or > 470 msec in females)
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Significant blood donation (or testing) in previous 8 weeks
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Use of any Investigational Product in previous 6 weeks (small molecule products) or previous 3 months (biologic products)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | West Coast Clinical Trials | Costa Mesa | California | United States | 92626 |
Sponsors and Collaborators
- MicroDose Therapeutx, Inc
Investigators
- Principal Investigator: Purvee Shah, MD, West Coast Clinical Trials
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MDT-637-CP-103