Acute Respiratory Distress SyndromePhase 1R-3750 ARDSNCT07646028
R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)
A Phase 1 study testing R-3750 in people with Acute Respiratory Distress Syndrome, run by Rise Therapeutics LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- R-3750
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- For subjects unable to provide consent, legally authorized representative (LAR) consent is obtainable in accordance with local regulations and Institutional Review Board (IRB)/Ethics Committee requirements.
- The investigator judges that the subject is likely to remain under protocol-compatible management and follow-up for the duration of the treatment and key follow-up period.
Who cannot join
- 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.
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- 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.
- Severe immunosuppression, including any of the following:
- Cytotoxic chemotherapy within 3 weeks prior to enrollment,
- High-dose corticosteroid exposure defined as cumulative prednisone ≥300 mg equivalent within 21 days prior to enrollment,
- Ongoing systemic corticosteroid therapy >15 mg/day prednisone equivalent within 7 days prior to enrollment, unless justified as part of standard ARDS care and approved by the Medical Monitor,
- Other severe acquired or iatrogenic immunodeficiency considered clinically significant by the investigator.
- Active uncontrolled infection outside the lung that, in the judgment of the investigator, would confound safety assessment or increase subject risk.
- Severe chronic respiratory disease likely to confound ARDS assessment or outcomes, including:
- Advanced COPD requiring chronic home oxygen,
- Clinically significant pulmonary fibrosis or interstitial lung disease,
- Other severe chronic lung, chest wall, or neuromuscular disorders causing chronic respiratory failure.
- Diffuse alveolar hemorrhage due to vasculitis.
- Malignancy or other irreversible chronic condition for which estimated 6-month mortality is ≥50%, in the investigator's judgment.
- Morbid obesity or body habitus that would substantially impair protocol assessments or ventilatory interpretation, if deemed clinically significant by the investigator.
- Any condition that, in the opinion of the investigator or Medical Monitor, would make participation unsafe, interfere with interpretation of study results, or be inconsistent with study objectives.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunomodulatory Effects of R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)
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:
- the favorable safety profile
- 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.
Read the detailed description
Acute Respiratory Distress Syndrome (ARDS) is a severe inflammatory lung condition characterized by diffuse alveolar damage, impaired gas exchange, respiratory failure, and significant morbidity and mortality. Patients with late-stage, non-resolving ARDS often remain dependent on mechanical ventilation and have limited therapeutic options beyond supportive care. Persistent inflammation and immune dysregulation are believed to contribute to ongoing lung injury, delayed recovery, and prolonged ventilator dependence.
R-3750 is an investigational orally administered biotherapeutic designed to modulate immune responses and promote restoration of immune homeostasis. This study will evaluate the safety, tolerability, and preliminary clinical activity of R-3750 in patients with late-stage, non-resolving ARDS.
The primary objective of this clinical trial is to assess the safety and tolerability of R-3750 when administered daily to hospitalized patients with persistent ARDS. Safety evaluations will include the assessment of adverse events (AEs), serious adverse events (SAEs), laboratory parameters, vital signs, and other clinically significant findings throughout the study period.
Secondary and exploratory objectives include evaluating potential clinical benefits associated with R-3750 treatment, including:
Reduction in ventilator dependence and duration of mechanical ventilation. Improvement in pulmonary function and respiratory status. Improvement in oxygenation parameters. Changes in inflammatory and immune-related biomarkers. Assessment of overall clinical recovery and disease progression. Evaluation of survival and other clinically relevant outcomes.
Participants will receive R-3750 once daily as oral capsules. For participants unable to swallow capsules, study treatment may be administered enterally through a nasogastric (NG) or orogastric (OG) feeding tube in accordance with study procedures. Participants will undergo regular safety assessments, clinical evaluations, and laboratory monitoring throughout the treatment and follow-up periods.
The results of this study will provide important information regarding the safety profile of R-3750 and its potential to improve clinical outcomes in patients with late-stage, non-resolving ARDS, a population with substantial unmet medical need.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- R-3750
- Keywords
- ARDS, Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-3750Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: R-3750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 through Day 90, including the 28-day treatment period and subsequent follow-up assessments.
Secondary outcomes (3)
All-cause mortality
Proportion of participants who are alive at Day 90.
Measured: Day 90
Ventilator-free days
Number of days alive and free from invasive mechanical ventilation.
Measured: Day 28
Organ failure-free days
Number of days alive and free from organ failure.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646028
- Sponsor's protocol ID
- RISE-3750-01AR
- Acronym
- R-3750 ARDS
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunomodulatory Effects of R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT07646028
- Acronym / sponsor ID
- R-3750 ARDS / RISE-3750-01AR
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Acute Respiratory Distress Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the favorable safety profile
- 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.
Detailed description
Acute Respiratory Distress Syndrome (ARDS) is a severe inflammatory lung condition characterized by diffuse alveolar damage, impaired gas exchange, respiratory failure, and significant morbidity and mortality. Patients with late-stage, non-resolving ARDS often remain dependent on mechanical ventilation and have limited therapeutic options beyond supportive care. Persistent inflammation and immune dysregulation are believed to contribute to ongoing lung injury, delayed recovery, and prolonged ventilator dependence.
R-3750 is an investigational orally administered biotherapeutic designed to modulate immune responses and promote restoration of immune homeostasis. This study will evaluate the safety, tolerability, and preliminary clinical activity of R-3750 in patients with late-stage, non-resolving ARDS.
The primary objective of this clinical trial is to assess the safety and tolerability of R-3750 when administered daily to hospitalized patients with persistent ARDS. Safety evaluations will include the assessment of adverse events (AEs), serious adverse events (SAEs), laboratory parameters, vital signs, and other clinically significant findings throughout the study period.
Secondary and exploratory objectives include evaluating potential clinical benefits associated with R-3750 treatment, including:
Reduction in ventilator dependence and duration of mechanical ventilation. Improvement in pulmonary function and respiratory status. Improvement in oxygenation parameters. Changes in inflammatory and immune-related biomarkers. Assessment of overall clinical recovery and disease progression. Evaluation of survival and other clinically relevant outcomes.
Participants will receive R-3750 once daily as oral capsules. For participants unable to swallow capsules, study treatment may be administered enterally through a nasogastric (NG) or orogastric (OG) feeding tube in accordance with study procedures. Participants will undergo regular safety assessments, clinical evaluations, and laboratory monitoring throughout the treatment and follow-up periods.
The results of this study will provide important information regarding the safety profile of R-3750 and its potential to improve clinical outcomes in patients with late-stage, non-resolving ARDS, a population with substantial unmet medical need.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 9E9 CFU/day | Experimental | Drug: R-3750Participants 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. |
| Cohort 2: 9E10 CFU/day | Experimental | Drug: R-3750Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-3750R-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. | Drug | Cohort 1: 9E9 CFU/day, Cohort 2: 9E10 CFU/day |
Primary outcome
To assess the safety and tolerability of R-3750 administered to participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS)
Time frame: From Day 1 through Day 90, including the 28-day treatment period and subsequent follow-up assessments.
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.
3 secondary outcomes
All-cause mortality
Time frame: Day 90
Ventilator-free days
Time frame: Day 28
Organ failure-free days
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-3750 in people with Acute Respiratory Distress Syndrome, run by Rise Therapeutics LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet L Stephens, PhD (650-417-8556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of R-3750 administered to participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) (time frame: From Day 1 through Day 90, including the 28-day treatment period and subsequent follow-up assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.