A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 Administered to Healthy Volunteers for 10 Days

Conditions
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Drug Safety

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception 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 as determined by medical history, physical examination, spirometry, ECG and clinical laboratory tests Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing Exclusion Criteria: Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and Sponsor (MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637 Evidence of current or history of respiratory disease; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis. Upper respiratory tract infection within 6 weeks of Visit 1 Symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of Visit 1 Current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms 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 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 Inability to perform reproducible spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines Abnormal QTc interval at Visit 1(>450 msec in males or > 470 msec in females) Significant blood donation (or testing) in previous 8 weeks

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDT-637<br>Active formulation | Drug: MDT-637<br>* Inhaled doses of MDT-637 over a 10 day period<br>|
| Placebo Comparator: Placebo<br>Matched Placebo Comparator | Drug: MDT-637<br>* Inhaled doses of MDT-637 over a 10 day period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers | Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events. | Up to 48 days (including up to 28 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 during the dosing period, 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