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Study of Safety and Efficacy of ALT-100mAb in Participants With Moderate/Severe ARDS

NCT05938036 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-23

No results posted yet for this study

Summary

A Phase 2a, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ALT-100mAb in patients with moderate to severe ARDS.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

DRUG

ALT-100 mAb

Experimental: Part A : ALT-100 mAB (Dose Escalation) 90 eligible participants will be randomized at a 2:1 ratio to receive a single dose of ALT-100 mAb.

DRUG

ALT-100 (Placebo)

Normal saline solution via IV solution

Sponsors & Collaborators

  • Aqualung Therapeutics Corp.

    lead INDUSTRY

Principal Investigators

  • Stan Miele · Aqualung Therapeutics Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2027-05-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938036 on ClinicalTrials.gov