COPD (Chronic Obstructive Pulmonary Disease)Phase 1R-3750-01-LUNCT07076290
A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD
A Phase 1 study testing R-3750 in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD Exacerbation, run by Rise Therapeutics LLC.
Trial summary
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 40 to 82 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbation, COPD Exacerbation Acute
- What is being tested?
- R-3750
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 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 40 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1>20% and ≤80% of predicted normal values
- Baseline mMRC dyspnea score 1 to 3
- Post-bronchodilator FEV1 > 50% predicted (GOLD COPD grade 1-2)
- Smoking pack years ≥ 10 years
- Age ≥ 40 years
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- Acceptable standard-of-care COPD maintenance therapy includes long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), or combinations thereof (e.g., dual LABA/LAMA, or triple LABA/LAMA/ICS therapy). The patient must have been on a stable dose and regimen for at least 4 weeks prior to screening with no changes anticipated during the study unless medically necessary.
- A history of ≥ 1 exacerbations in the last 12 months
- Be able to provide written consent; compliant with study procedures and study visits.
Who cannot join
- Patients whose treatment is considered palliative (life expectancy <12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis
- Current smoker or cessation within 3 months of screening, or current use of vaping device
- Patients with pneumonia or COPD exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1
- Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure [e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)] that will affect the study.
- Myocardial infarction, unstable angina or stroke within 12 months prior to screening
- Diagnosis of malignancy within 5 years of study Day 1(except for excised localized carcinoma of skin not including malignant melanoma)
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- Clinically significant ECG changes, which in the opinion of investigator warrants further investigations
- Evidence of alcohol, drug or solvent abuse.
- Pregnant, breastfeeding, or lactating women. Women of child-bearing potential (i.e. not surgically sterilized or post- menopausal) must have a negative blood serum pregnancy test performed at the screening visit and must agree to use two methods of birth control (one of which must be a barrier method) for at least 3 months past the last day on the study.
- Participation in an interventional clinical study within 3 months of study Day 1 or receipt of any investigational medicinal product within 3 months or 5 half- lives.
- Lung volume reduction surgery or bronchoscopic lung volume reduction within the last 12 months.
- Historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis, or Eosinophilic Esophagitis.
- Cirrhosis or current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
- Active blood born infection (e.g. HIV, Hepatitis A, B or C)
- Current or recent (<2 weeks) treatment with oral steroids, theophylline, chronic azithromycin or other methylxanthines, roflumilast, or Dupixent
- Current infection or antibiotic treatment
- Use of probiotics within 2 weeks of study Day 1
- Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD)
- Subjects receiving treatment with oxygen more than 4.0 Litres/minute (L/min). While breathing supplemental oxygen, subjects should demonstrate oxyhemoglobin saturation greater than or equal to 89 percent.
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
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
Read the detailed description
Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and scored measure of their chronic obstructive pulmonary disease (COPD). Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
- Being tested
- R-3750
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-3750Drug
R-3750 DP; Lactococcus lactis expressing Surface Layer Protein A (SlpA)
| Study group | Role | What they receive |
|---|---|---|
| Open Label R-3750 | Other | Open Label Drug - R-3750 Receives: Drug: R-3750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the treatment-related adverse events of R-3750
To assess the number of participants with treatment-related adverse events after taking R-3750 (probiotics)
Measured: 12 weeks
Secondary outcomes (1)
Clinical Response based on St. George's Respiratory Questionnaire (SGRQ)
To assess the number of participants that show improvements in the chronic obstructive pulmonary disease (COPD) severity by collecting the St. George's Respiratory Questionnaire (SGRQ). The scores are based on a numbering system ranging from 0-100 where the higher number indicates a worse condition. The scores will be compared from the beginning of the trial and again at different times to the end to see if there are any changes in symptoms before and after taking R-3750 (probiotic).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 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 COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT07076290
- Sponsor's protocol ID
- RISE-3750-01LU
- Acronym
- R-3750-01-LU
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD
- ClinicalTrials.gov ID
- NCT07076290
- Acronym / sponsor ID
- R-3750-01-LU / RISE-3750-01LU
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jul 2025 (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 study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
Detailed description
Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and scored measure of their chronic obstructive pulmonary disease (COPD). Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Open Label R-3750 | Other | Drug: R-3750Open Label Drug - R-3750 |
Who may qualify
- Ages
- 40 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1>20% and ≤80% of predicted normal values
- Baseline mMRC dyspnea score 1 to 3
- Post-bronchodilator FEV1 > 50% predicted (GOLD COPD grade 1-2)
- Smoking pack years ≥ 10 years
Key exclusion criteria (20 listed)
- Patients whose treatment is considered palliative (life expectancy <12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis
- Current smoker or cessation within 3 months of screening, or current use of vaping device
- Patients with pneumonia or COPD exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1
- Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure [e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)] that will affect the study.
- Myocardial infarction, unstable angina or stroke within 12 months prior to screening
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 DP; Lactococcus lactis expressing Surface Layer Protein A (SlpA) | Drug | Open Label R-3750 |
Primary outcome
To assess the treatment-related adverse events of R-3750
Time frame: 12 weeks
To assess the number of participants with treatment-related adverse events after taking R-3750 (probiotics)
1 secondary outcome
Clinical Response based on St. George's Respiratory Questionnaire (SGRQ)
Time frame: 12 weeks
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 29 Jan 2026.
- Individual participant dataSharing planned: No
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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 COPD (Chronic Obstructive Pulmonary Disease) and COPD Exacerbation, 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 9 inclusion and 20 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 29 Jan 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 (6504178556, 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 treatment-related adverse events of R-3750 (time frame: 12 weeks). 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 29 Jan 2026.