NCT03017547

A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Implicit Bioscience · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.

Detailed description

Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	IC14	Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS
OTHER	Placebo	sterile normal saline for infusion

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-01-11
• Last updated: 2025-08-20

Regulatory

• FDA-regulated drug study