NCT07449572

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: HTIC, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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 size: 8 participants per cohort (6 assigned to HT31-1 and 2 assigned to placebo). Randomization: 3:1 ratio (HT31-1: placebo). Blinding: HT31-1 and placebo will be provided as identical, indistinguishable investigational products supplied by the Investigational Pharmacy. Both participants and all study site personnel (including investigators, study staff, and safety assessors) will remain blinded to treatment allocation. Randomization codes will be maintained by an independent statistician or designated unblinded party and will not be disclosed until database lock unless required for subject safety. Population: Approximately 24 healthy adult volunteers. Dosing: A single intravenous infusion of HT31-1 per cohort at ascending dose levels of 1 mg/kg, 5 mg/kg, and 20 mg/kg. Dose escalation will proceed in a sentinel dosing format with interim safety reviews between cohorts. Each cohort will enroll 8 participants (6 HT31-1, 2 placebo). A total of up to 24 participants will be enrolled in Part A. No additional expansion cohort is planned.

Conditions

• ARDS (Acute Respiratory Distress Syndrome)

Interventions

Type	Name	Description
DRUG	HT31-1	HT-1 is a humanized monoclonal antibody developed by HTIC, Inc as a treatment for Acute Respiratory Distress Syndrome (ARDS) Due to an Infectious Source
OTHER	Saline (0.9%, sterile, for infusion)	Saline is as placebo control

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study