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R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)

NCT07646028 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-12

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if R-3750 is safe in \[in patients with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) . The main question\[s\] it aims to answer are:

1. the favorable safety profile
2. clinical improvement that includes reduced ventilator dependence and improved lung function.

Participants will be given oral capsules daily and/or enteral nasogastric or orogastric (NG/OG tube) if necessary.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

R-3750

R-3750 is an investigational live biotherapeutic product administered once daily at either 9 × 10⁹ CFU/day or 9 × 10¹⁰ CFU/day. Study treatment may be administered orally as capsules or enterally via nasogastric (NG) or orogastric (OG) tube when oral administration is not feasible.

Sponsors & Collaborators

  • Rise Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-10-31
Completion
2028-12-31
FDA Drug
Yes

More Related Trials

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 NCT07646028 on ClinicalTrials.gov