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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Participants must meet all of the following criteria: 1. Age 18 to 65 years old, inclusive, at the time of consent. 2. Able and willing to provide written informed consent and to comply with all study procedures and requirements. 3. Healthy as determined by medical history, physical examination, and baseline investigations. No clinically significant abnormalities on physical exam. 4. Body Mass Index (BMI) between 18.0 and 32.0 kg/m², inclusive. 5. Vital signs and 12-lead ECG without clinically significant abnormalities, in the investigator's judgment, at screening (e.g.,…
Interventions
- DrugHT31-1
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
- OtherSaline (0.9%, sterile, for infusion)
Saline is as placebo control
Location
- Virginia Commonwealth University (VCU Health)Richmond, Virginia