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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 in Healthy Volunteers

Conditions
-----------------
Drug Safety, Respiratory Syncytial Virus Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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, 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 MDT 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, including asthma, emphysema, chronic bronchitis, or cystic fibrosis 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 serum pregnancy test at Visit 1 Inability to perform reproducible spirometry Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC < 85% of predicted and variability of <5% or FEV1/FVC ratio < 0.7) 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
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 24 hour period<br>|
| Placebo Comparator: Placebo<br>Matched Placebo Comparator | Drug: MDT-637<br>* Inhaled doses of MDT-637 over a 24 hour period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of 6 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 22 days (including 14 day 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 as defined by Cmax | Multiple plasma samples collected up to 24 hours post first dose | 
| Trough MDT-637 Nasal Concentration | Determination of MDT-637 concentration following nasal wash | 24 hours | 
| Plasma pharmacokinetics for MDT-637 dry powder inhalation | Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax | 24 hours | 
| Plasma pharmacokinetics of MDT-637 dry powder inhalation | Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RSV