A Phase 1/2A Randomized Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 (hCitH3-mAb) in Healthy Volunteers and Patients With Mild-to-Moderate ARDS

What this Trial Is About

Researchers are evaluating HT31-1 (hCitH3-mAb), a humanized monoclonal antibody, for its safety, tolerability, and pharmacokinetics in both healthy adults and patients with mild-to-moderate acute respiratory distress syndrome (ARDS) caused by infection. This Phase 1/2A randomized, double-blind study aims to understand the drug's effects and help determine the appropriate dose for future studies by focusing initially on healthy volunteers. HT31-1 targets a key factor involved in inflammation and tissue damage in ARDS without affecting the body's natural immune defense. Participants will receive a single intravenous dose of HT31-1 at one of three ascending dose levels: 1 mg/kg, 5 mg/kg, or 20 mg/kg, or a matching placebo (saline). Each dose group will include 8 participants, with 6 receiving HT31-1 and 2 receiving placebo. The study uses a randomized, double-blind, placebo-controlled design with careful safety monitoring and dose escalation between cohorts. No additional expansion cohorts are planned beyond the initial 24 healthy volunteers. During the study, participants will undergo safety assessments, including monitoring for adverse events and serious adverse events over 28 days. Researchers will also study how the drug behaves in the body by measuring blood levels and evaluating early biological activity through pharmacodynamic and biomarker tests. Participants will have physical exams, lab tests, ECGs, and follow-up visits to ensure safety and collect necessary data. The total participation time per volunteer will cover the dosing and 28 days of monitoring.

Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS