Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03522935
Study type Interventional
Source Stanford University
Status Not yet recruiting
Phase Phase 1
Start date May 15, 2018
Completion date May 15, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Recruiting NCT01712620 - Spironolactone for Pulmonary Arterial Hypertension Phase 2
Recruiting NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Recruiting NCT03497689 - EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension Phase 4
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Not yet recruiting NCT02845518 - Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA) N/A
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Recruiting NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00741819 - Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects Phase 4
Completed NCT00709098 - Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension Phase 3