CompletedPhase 1

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

United States10 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.

Timeframe: Up to 61 days (including up to 42 days of screening period)

Trial details

NCT IDNCT01556607

SponsorMicroDose Therapeutx, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

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