Subcutaneous Elafin in Healthy Subjects (NCT03522935) | Clinical Trial Compass
CompletedPhase 1
Subcutaneous Elafin in Healthy Subjects
United States30 participantsStarted 2019-03-18
Plain-language summary
A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH. Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period.
Who can participate
Age range
18 Years – 55 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
. Male or female, 18 - 55 years of age
. No history or clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health at screening examination.
. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
. Informed consent.
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
1
Incidence of Treatment-Emergent Adverse Events in healthy controls.
. Females of childbearing potential must use an acceptable form of contraception at time of enrollment (and throughout the duration of study) including, but not limited to the following:
Exclusion criteria
. Administration of any investigational drug 45 days prior to study enrollment.
. Active participation in another interventional clinical trial.
. Use of any prescription medication within 30 days (with exception to oral contraceptives) or over-the-counter medication (OTC) within 7 days before first study drug administration. Use of OTC medications may be permitted after day 1 visit until end of study with approval of the protocol investigator.
. Subject performed heavy physical exertion 2 days before eligibility assessment and before admission into clinical research center.
. Subject consumes more than 500 mL of beer/day or 250 mL of wine/day or 2 glasses of liquor/day.
. Subject has a history of chronic alcohol or drug abuse within the last 4 weeks.
. Subject smokes more than 10 cigarettes per day or has done so within 6 months prior to eligibility assessment.
. Subject has a diet that deviates notably from the "normal" amounts of protein, carbohydrate, and fat, as judged by the investigator (e.g., vegetarians or vegans).