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Monoclonal Antibodies

ALT-100mAb for Acute Respiratory Distress Syndrome

Phase 2

Recruiting

Research Sponsored by Aqualung Therapeutics Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiological abnormalities on chest x-ray or computed tomography (CT) scan, ie, bilateral opacities that are not fully explained by effusions, nodules, masses, or lobar/lung collapse.

OR Participant presents with acute respiratory failure phenotypically similar to ARDS in a setting demonstrating clinical risk for ARDS, whether or not they meet the Berlin criteria, and requiring heated and humidified HFNC 30 L/min and above and 100 percent FiO2, or NIPPV (ie, BiPAP/CPAP) for hypoxemia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Summary

This trial is testing a new drug called ALT-100mAb in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) to see if it is effective and safe.

Who is the study for?

This trial is for adults over 18 with moderate to severe ARDS, a type of lung failure that happens quickly after an injury or infection. They must have certain blood oxygen levels and be able to start treatment within specific time frames. Pregnant women can't join, and participants need to consent to the study's rules.

What is being tested?

The trial tests ALT-100mAb against a placebo in patients with ARDS. It's a Phase 2a study where patients are randomly assigned treatments without knowing which one they're getting (double-blind) across multiple hospitals.

What are the potential side effects?

While the side effects of ALT-100mAb aren't specified here, similar drugs may cause immune reactions, infusion-related discomforts, possible organ inflammation, and could affect how other medications work.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My chest X-ray or CT scan shows unusual shadowing not caused by other known lung issues.

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I have severe breathing problems similar to ARDS and need high-flow oxygen or non-invasive ventilation.

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I will receive the study treatment within 12 hours of my ARDS diagnosis and within 4 hours if I need a ventilator.

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I have moderate ARDS with specific oxygen and pressure levels.

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I am 18 or older and will be hospitalized or have plans for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the Safety and tolerability of a single intravenously (IV) infused dose of ALT-100 in participants with moderate to severe ARDS: Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).

Secondary study objectives

Number of participants with abnormal clinical vital signs

Number of participants with abnormal clinically significant clinical laboratory results

PK of single IV infused dose of ALT-100

+16 more

Other study objectives

Exploratory - To assess the effect of ALT-100 on respiratory support requirements over time: MVFDs by Days 8, 15, 22, and 60.

Exploratory - To assess the effect of ALT-100 on respiratory support requirements over time: Number of participants progressing from non-invasive to invasive MV by Days 8, 15, 22, 29, and 60.

Exploratory - To assess the effect of ALT-100 on respiratory support requirements over time: Proportion of participants not on MV support on Days 8, 15, 22, 29, and 60.

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B (Dose Expansion) ALT-100 mAbExperimental Treatment1 Intervention

Approximately 9 participants in each cohort in Part A, additional participants (up to 36 per dose cohort) may be enrolled into 2 dose expansion cohorts, the dose of which will be determined by the SRC. Drug: AT-02 Dosage: Will be decided by the SCR Route of Admin: Solution for IV Infusion

Group II: Part A : ALT-100 mAB (Dose Escalation)Experimental Treatment1 Intervention

90 eligible participants will be randomized at a 2:1 ratio to receive a single dose of ALT-100 mAb. Part A will assess 2 doses of ALT-100 mAb in sequentially enrolled cohorts of up to 9 participants in each cohort. (Randomised, Double-blind) Drug: ALT-100 mAb Dosage Form: Sterile liquid, pH 5.5, Dosage: 0.4 mg/kg (Cohort 1a) and 1.0 mg/kg (Cohort 2a) Dosage Form \& Route of Admin: Solution for IV Infusion

Group III: Part A PlaceboPlacebo Group1 Intervention

Part A participants with acute respiratory distress syndrome (ARDS) (Randomised, Double-blind) Dosage Form \& Route of Admin: Normal Saline Solution for IV Infusion

0 / 5Eligibility criteria met