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About
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.
Full description
There will be a total of up to 30 subjects randomly assigned to 5 groups with 6 subjects in each group. One subject in each group will be assigned to placebo drug and 5 subjects to active drug. Subjects in each group will receive a single daily dose of Elafin/Placebo for total of 7 days. There will be ascending doses across groups. Groups receiving a higher dose will only do so after the previous group has completed dosing (i.e., 7 days). Each subject will be followed over a 28 day time period.
An interim trial analysis will occur after completion of the 2nd cohort in order for the research team to review PK and safety data to determine modification (if needed) of dosing strategy for groups 3-5. The study is also designed to absorb a de-escalation strategy. If the protocol requires a lowering of dose from the initial dosing, a new group will be assigned a low-dose subcutaneous Elafin regimen.
The study will conclude at any dose that produces clinically significant adverse effects and identified as Maximum Tolerated Dose (MTD).
Enrollment
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Inclusion criteria
A subject will be eligible only if all of the following criteria apply:
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.
Normal or clinically acceptable ECG
Normal blood pressure (systolic: 90 - 140 mmHg; diastolic: 50 - 90 mmHg) and heart rate (45 - 100 bpm)
Body mass index of 18.0 - 32.0 (kg/m2)
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:
Males must agree to use a barrier method of birth control from 30 days before first study drug administration until 90 days after last study drug administration.
Exclusion criteria
A subject will not be eligible if any of the following criteria apply:
Primary purpose
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30 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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