NCT07449572 is a Phase 1 clinical trial of HT31-1 in ARDS (Acute Respiratory Distress Syndrome), sponsored by HTIC, Inc.

Who is sponsoring NCT07449572?

NCT07449572 is sponsored by HTIC, Inc.

What drugs are being tested in NCT07449572?

Interventions in NCT07449572: HT31-1, Saline (0.9%, sterile, for infusion).

What condition does NCT07449572 study?

NCT07449572 studies ARDS (Acute Respiratory Distress Syndrome).

Is NCT07449572 still recruiting?

NCT07449572 is currently recruiting now. Last updated 20 May 2026.

Last reviewed 2026-05-20 · How we verify

NCT07449572

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Recruiting now Phase 1 Last updated 20 May 2026

What this trial tests

Phase 1 trial testing HT31-1 in ARDS (Acute Respiratory Distress Syndrome) in 24 participants. Currently enrolling.

Timeline

1 May 2026

Primary endpoint
1 November 2026

1 November 2026

Quick facts

Lead sponsor	HTIC, Inc
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	1 May 2026
Primary completion	1 November 2026
Estimated completion	1 November 2026
Sites	2 locations across United States

Drugs / interventions tested

HT31-1 — full drug profile →
Saline (0.9%, sterile, for infusion) — full drug profile →

Conditions studied

ARDS (Acute Respiratory Distress Syndrome) — all drugs for ARDS (Acute Respiratory Distress Syndrome) →

Sponsor

HTIC, Inc — full company profile →

Who can join

Adults 18 to 65, any sex, with ARDS (Acute Respiratory Distress Syndrome). Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 0-28 days
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of HT31-1.
Assess dose-limiting toxicities (DLTs)
Time frame: 0-28 days
Number and percentage of participants experiencing DLTs at each dose level.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for ARDS (Acute Respiratory Distress Syndrome)

Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07449572 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HTIC, Inc
Last refreshed: 20 May 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07449572.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing