Not Yet RecruitingPhase 1

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

20 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial focused on safety and tolerability rather than proving the treatment works, what does that mean for what we can realistically expect in terms of benefit versus risk for someone in my situation?
2This trial is specifically for 'late-stage, non-resolving ARDS' — how would you determine whether my condition meets that definition, and are there standard treatments that should still be tried before considering a study like this?
3Since the trial isn't recruiting yet, how much time might pass before it opens, and given how rapidly ARDS can progress, does waiting for this study even make sense as part of my care plan?
4R-3750 appears to be a new investigational drug with limited human data — what do you know about how it works, and what kinds of side effects or unknowns should we be prepared for in a first-in-ARDS Phase 1 study?
5If I were to enroll in this trial once it opens, what would day-to-day participation actually look like for someone with late-stage ARDS — including monitoring, hospital stays, and what happens if my condition changes during the study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07646028

SponsorRise Therapeutics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-31

Contact for this trial

Janet L Stephens, PhD

650-417-8556 jstephens@risetherapeutics.com

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials