Subcutaneous Elafin in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT03522935 |
Recruitment Status :
Completed
First Posted : May 14, 2018
Last Update Posted : April 28, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | February 1, 2018 | ||||
First Posted Date ICMJE | May 14, 2018 | ||||
Last Update Posted Date | April 28, 2021 | ||||
Actual Study Start Date ICMJE | March 18, 2019 | ||||
Actual Primary Completion Date | October 25, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence of Treatment-Emergent Adverse Events in healthy controls. [ Time Frame: 28 day time period ] Safety and tolerability will be determined on the basis of adverse events reported and the severity of adverse events.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Pharmacokinetic/pharmacodynamic (PK/PD) and immunogenicity parameters in blood sample: AUC0-last [ Time Frame: 28 day time period ] AUC0-last: Area under the concentration time-curve to the last concentration above the lower limit of quantitation (after final dose consumed)
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Subcutaneous Elafin in Healthy Subjects | ||||
Official Title ICMJE | Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects | ||||
Brief 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. | ||||
Detailed 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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Arterial Hypertension | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 18, 2020 | ||||
Actual Primary Completion Date | October 25, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: A subject will be eligible only if all of the following criteria apply:
Exclusion criteria: A subject will not be eligible if any of the following criteria apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03522935 | ||||
Other Study ID Numbers ICMJE | 42336 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Roham T. Zamanian, Stanford University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Roham T. Zamanian | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Stanford University | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |