A Phase 1/2A, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 (hCitH3-mAb) in Healthy Volunteers and in Patients With Mild-to-Moderate ARDS: Part A (Healthy Volunteers)
HTIC, Inc
Summary
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source. The current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.
Description
HT31-1 injection is a first-in-class humanized monoclonal antibody that neutralizes citrullinated histone H3 (CitH3), a critical damage-associated molecular pattern (DAMP) driving neutrophil extracellular trap (NETosis-induced endothelial injury, microvascular thrombosis, and hyper-inflammation in sepsis and ARDS. HT31-1 addresses the underlying pathophysiology of sepsis/ARDS without impacting the innate immune defense function, thus provide a potentially safe and effective means to treat ARDS. Design: Randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. Cohort si…