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 range18 Years – 55 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events in healthy controls.
. 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).