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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
HTIC, Inc
Study ID
NCT07449572
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HT31-1 — DRUG
    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
  • Saline (0.9%, sterile, for infusion) — OTHER
    Saline is as placebo control

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: 1 mg/kg
    HT31-1 1mg/kg single intravenous dosing
  • Placebo Comparator: Cohort 1: Placebo
    Saline single intravenous dosing
  • Experimental: Cohort 2: 5 mg/kg
    HT31-1 5mg/kg single intravenous dosing
  • Placebo Comparator: Cohort 2: Placebo
    Saline single intravenous dosing
  • Experimental: Cohort 3: 20 mg/kg
    HT31-1 20mg/kg single intravenous dosing
  • Placebo Comparator: Cohort 3: Placebo
    Saline single intravenous dosing

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 0-28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth University (VCU Health)RichmondVirginia23298
Lacey Harris, MPH, BSN
[email protected]
804-828-0404
Virginia Commonwealth University (VCU Health)RichmondVirginia23298
Lacey Harris, MPH, BSN
[email protected]
804-828-0404

Find similar trials in Richmond, VA

By research site
Virginia Commonwealth University (VCU Health)· Richmond, VA

Related Studies