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

Completed · Phase 1 · Has a placebo group

Conditions studied: Drug Safety

In brief

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.

Key facts

Study ID

NCT01556607

Run by

MicroDose Therapeutx, Inc

People needed

10

Starts

2012-03-01

Expected to finish

2012-05-01

Last updated by the study team

2012-05-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• West Coast Clinical Trials — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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