A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

Conditions

• Respiratory Distress Syndrome, Acute

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• GEn-1124 — DRUG
  Intravenous infusion
• Placebo — DRUG
  Intravenous infusion

Study Details

GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.

Key Dates

Start date

Apr 4, 2023

Status verified

Oct 2025

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

52 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Cohort 1: GEn-1124
  Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.
• Experimental: Part 1 Cohort 2: GEn-1124
  Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.
• Placebo Comparator: Placebo
  Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).
• Experimental: Part 2: GEn-1124
  Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.

Primary Outcome Measure

To assess the safety and tolerability (SAEs and TEAEs) of GEn-1124 [ Time Frame: Through study completion, Day 60 ]

Central Contacts

• Ritu Lal, PhD, MS
  (650) 248-2429
  [email protected]

Locations (11)

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