A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

Официальное название

A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

Обзор

GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.

Подробное описание

Randomized , double-blind, placebo controlled, dose escalation study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GEn1124.

GEn-1124 or placebo will be administered as a 2-hour IV infusion as early as possible after ARDS diagnosis. Participants will receive a second dose approximately 8 hours after the first and will continue BID for the remaining schedule (Days 2-5). Follow-up will be for a total of 60 days after the first dose or death (whichever comes first).

An independent Safety Review Committee (SRC) will be responsible for reviewing data throughout the study.

Вмешательства

• Препарат GEn-1124
  Intravenous infusion
• Препарат Placebo
  Intravenous infusion

Первичные конечные точки

• To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124 [Срок оценки: Through study completion, Day 60]

Критерии участия

Критерии включения

• Male or female subject between the ages of 18 and 85 years old, inclusive.
• Written informed consent .
• Dosing as early as possible after first meeting ARDS 2023 Global definition.
• Acceptable method of birth control.

Критерии исключения

• Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.
• Pregnant or breastfeeding
• Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.
• Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.
• Any other irreversible disease or condition for which 6-month mortality is estimated to be >50%.
• Moderate to severe liver failure.
• Estimated glomerular filtration rate (eGFR) <10 mL/min/1.73 m2 or requiring dialysis at screening.
• Subjects with known:

• New York Heart Association Class IV heart disease; or
• Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or
• Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.
• Severe chronic respiratory disease with continuous home oxygen >2 liters per minute (LPM) or >28% (adjusted for altitude); and/or home noninvasive ventilation (except for the treatment of obstructive sleep apnea).
• Poly-traumatic injury resulting in significant blood loss and/or likely to require major surgery within the study period, or subject condition that would interfere with study procedures.
• History of any type of solid organ or cellular transplant.
• Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and/or other chronic conditions.
• Moribund subject not expected to survive 24 hours.
• Do not resuscitate (DNR) status.
• World Health Organization (WHO) functional class III or IV pulmonary hypertension.
• Subject has been on mechanical ventilation for more than 7 days at time of dosing.
• Burn victims currently undergoing treatment for >40% total body surface area (TBSA) involvement or for known airway inhalation injury.
• Neuromuscular disease that could impact ability to wean from mechanical ventilation.
• History of tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of Screening of a positive TB test).
• Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.
• Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.
• Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Medstar Washington Hospital Center — Washington D.C.
• University of Kansas Medical Center — Kansas City
• University of Maryland Medical Center — Baltimore
• University of Maryland - Baltimore Washington Medical Center — Glen Burnie
• Ocean Springs Hospital — Ocean Springs
• Washington University School of Medicine — St Louis
• Cooper University Hospital — Camden
• The Mount Sinai Hospital — New York
• … и ещё 3 центра

Идентификаторы

NCT: NCT05795465 · GEn-1124-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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