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

NCT07646028 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RISE-3750-01AR
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of R-3750 administered to participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS)

  To assess the number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters, abnormal vital signs, abnormal physical examination findings throughout the study.

  From Day 1 through Day 90, including the 28-day treatment period and subsequent follow-up assessments.

Secondary Outcomes (3)

• All-cause mortality

  Day 90

• Ventilator-free days

  Day 28

• Organ failure-free days

  Day 28

Study Arms (2)

Cohort 1: 9E9 CFU/day

EXPERIMENTAL

Participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) will receive R-3750 at a dose of 9 × 10⁹ CFU/day administered once daily. Study treatment may be administered orally as capsules or enterally via nasogastric (NG) or orogastric (OG) tube if required.

Drug: R-3750

Cohort 2: 9E10 CFU/day

EXPERIMENTAL

Participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) will receive R-3750 at a dose of 9 × 10¹⁰ CFU/day administered once daily. Study treatment may be administered orally as capsules or enterally via nasogastric (NG) or orogastric (OG) tube if required.

Drug: R-3750

Interventions

R-3750 DRUG

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.

Cohort 1: 9E9 CFU/day; Cohort 2: 9E10 CFU/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of consent.
• Acute Respiratory Distress Syndrome (ARDS) meeting the contemporary clinical definition including all of the following occurring within a 24-hour interval:
• Hypoxemia defined as PaO2/FiO2 ≤300 mmHg, or SpO2/FiO2 ≤315 if SpO2 is ≤97%;
• Bilateral pulmonary infiltrates/opacities on chest imaging consistent with pulmonary edema or fibroproliferative lung injury and not fully explained by pleural effusions, lobar collapse, or atelectasis;
• Requirement for positive pressure respiratory support, including invasive mechanical ventilation via endotracheal tube;
• Respiratory failure not fully explained by left atrial hypertension or cardiogenic pulmonary edema; if measured, pulmonary artery wedge pressure should be ≤18 mmHg.
• Late-stage, non-resolving ARDS, defined as:
• At least 7 days and no more than 28 days since ARDS onset at the time of enrollment; and
• Persistent bilateral infiltrates since ARDS onset; and
• Continued need for substantial respiratory support since ARDS onset.
• On the day of enrollment, ongoing respiratory impairment demonstrated by:
• PaO2/FiO2 ≤300 mmHg, or
• SpO2/FiO2 ≤315 if SpO2 is ≤97%.
• Subject is receiving invasive mechanical ventilation, or other protocol-defined intensive respiratory support as approved by the Sponsor/Medical Monitor.
• The treating team considers the subject an appropriate candidate for enteral administration of study drug, including by nasogastric (NG), orogastric (OG), or other enteral tube, and there is an intention to provide enteral nutrition or medication administration through the gastrointestinal tract.

You may not qualify if:

• Age \<18 years.
• More than 28 days since onset of ARDS at the time of enrollment.
• ARDS that is clearly resolving rapidly, in the judgment of the investigator, such that enrollment in a 28-day rescue-therapy study is not clinically appropriate.
• Pregnancy or breastfeeding.
• Participation in another interventional investigational drug or biologic study within 30 days prior to enrollment, or within 5 half-lives of the investigational product, whichever is longer, unless approved by the Sponsor and Medical Monitor.
• Extracorporeal support for gas exchange at the time of study entry, including ECMO.
• Inability to use the gastrointestinal tract for study drug administration, including but not limited to:
• Continuous gastric suction/drainage that would preclude dosing,
• Bowel discontinuity preventing enteral delivery,
• Open abdomen,
• Dependence on total parenteral nutrition with no enteral access,
• Other conditions that, in the investigator's judgment, make enteral dosing infeasible.
• Known or suspected bowel ischemia, gastrointestinal perforation, uncontrolled GI bleeding, or other severe gastrointestinal disorder that would substantially increase risk from enteral dosing.
• Not committed to full supportive care, with the exception that subjects with a do-not-resuscitate order may be eligible if all other indicated intensive supportive treatments are being provided.
• AIDS by CDC criteria, including documented AIDS-defining illness or CD4 count \<200 cells/mm³, if known.

Sponsors & Collaborators

• Rise Therapeutics LLC: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Janet L Stephens, PhD

CONTACT

650-417-8556; jstephens@risetherapeutics.com

Christian F Freguia, PhD

CONTACT

215-923-1818; cfreguia@risetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, sequential dose cohort study: * Cohort 1: 9E9 CFU/day (n=10) * Cohort 2: 9E10 CFU/day (n=10) Administration: • oral capsules and enteral (NG/OG tube) if required

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06