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

MicroDose Therapeutx, Inc1 site in 1 country36 target enrollmentDecember 2011

ConditionsDrug Safety

InterventionsMDT-637

DrugsMDT-637

Overview

Phase: Phase 1
Intervention: MDT-637
Conditions: Drug Safety
Sponsor: MicroDose Therapeutx, Inc
Enrollment: 36
Locations: 1
Primary Endpoint: Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

February 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MicroDose Therapeutx, Inc

Responsible Party

Sponsor

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, 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

Arms & Interventions

MDT-637

Active formulation

Intervention: MDT-637

Placebo

Matched Placebo Comparator

Intervention: MDT-637

Outcomes

Primary Outcomes

Safety and Tolerability of 3 escalating doses of MDT-637 dry powder inhalation in healthy volunteers

Time Frame: Up to 48 days (including up to 28 days of screening period)

Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.