IC14 for Treatment of Acute Decompensated Heart Failure
NCT Number: NCT06556810
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Acute Decompensated Heart Failure
Interventions: DRUG: Atibuclimab (IC14)
Sponsor: Implicit Bioscience
Collaborators: University of Virginia|Virginia Commonwealth University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-01-31
Locations: University of Virginia, Charlottesville, Virginia, 22908, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States

Summary:
The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. The main questions it aims to answer are:

Is the drug IC14 safe in patients with ADHF? What are the IC14 drug levels in the bloodstream after treatment with IC14? What is the impact of IC14 treatment on markers of disease in the bloodstream? What is the impact of IC14 treatment on measures of heart failure? There is no placebo arm in this study.

Participants will:

Take drug IC14 once via an intravenous infusion After the infusion, be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion

Primary Outcome Measures: Safety of IC14 treatment, safety measured by treatment-emergent adverse events, including abnormal laboratory values, 0-28 days|Safety of IC14 treatment, anti-drug antibodies, 0-28 days
Secondary Outcome Measures: C-reactive protein, biomarker of inflammation, area under the curve (0 \[normal\]; 1-10 mg/dL \[moderate elevation\]; \> 10 mg/dL \[marked elevation\] per time), baseline, 24 hours, 72 hours or discharge, Day 10, Day 29|B-type natriuretic peptide, biomarker of heart failure, absolute value (\<100 pg/mL \[normal\], \>=100 pg/mL \[heart failure\]), baseline, 24 hours, 72 hours or discharge, Day 10, Day 29|Estimated glomerular filtration rate, biomarker of heart failure, absolute value(\>=90 ml/min/1.73 m2 \[normal\]; 60-89 \[possible impairment\]; 15-59 \[impairment\]; \<15 \[renal failure\]), baseline, 72 hours or discharge, Day 10, Day 29|Urine sodium, absolute value (40-220 milliequivalents/day), baseline, 24 hours, 72 hours or discharge|Dyspnea Visual Analogue Scale, 10-cm Visual Analogue Scale, baseline, 24 hours, 72 hours, Day 10, Day 29, and 3 months (virtual).|Congestion Score, a composite score of one point for peripheral edema, jugular venous distension ≥10 cm, pulmonary rales, or S3 gallop (0 \[good\] to 4 \[poor\]), baseline, 24 hours, 72 hours, Day 10, and Day 29|Loop diuretic requirement, total loop diuretic requirement (in furosemide equivalents) as calculated from concomitant medication listings, during the first 72 hours of hospitalization|Doppler echocardiogram, Change from baseline in left ventricular ejection fraction (left ventricular ejection fraction (\>52% male, \>54% female \[normal\]), baseline, Day 10|Echocardiogram, Change from baseline in left ventricular global longitudinal strain (normal 21%), baseline, Day 10|Non-invasive hemodynamic assessment, Measure of cardiac output, baseline, 24 hours, 72 hours, Day 1|Bioimpedance analysis, Measure of extracellular fluid as a marker of heart failure, baseline, 24 hours, 72 hours, Day 1|Cardiopulmonary exercise test, aerobic exercise capacity (peak oxygen consumption \[VO2\]; \<30 mL/kg/min \[sedentary\]), Day 10|Pharmacokinetic determination of half-life, maximum concentration and area-under-the-curve, serum IC14 level, baseline, 15 minutes, 6 hours, 24 hours, 72 hours, Day 10, Day 29|Pharmacodynamics, Duration of monocyte CD14 receptor occupancy \>90%, Day 10, Day 29|Ex-vivo leukocyte release assay, Lipopolysaccharide-stimulated release of interleukin 6, Day 10