Pulmonary Fibroses, IdiopathicPhase 1NCT06589219
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing CMR316 in people with Pulmonary Fibroses, Idiopathic, run by Calibr, a division of Scripps Research at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibroses, Idiopathic
- What is being tested?
- CMR316
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2024to 23 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential, 18-60 years of age.
- Must agree to use a highly effective method of contraception.
- Body Mass Index (BMI) 18-33 kg/m2 as measured at screening.
- Weight ≤100 kg at screening.
- Normal lung function, defined as: FVC and FEV1 > 80% predicted (based on age, height, race, sex, SaO2 > 95% on room air.
- Heart rate between 50 and 90 beats per minute (BPM).
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- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination) and screening safety procedures.
- Diagnosis of IPF by American Thoracic Society/ERS (European Respiratory Society)/JRS (Japanese Respiratory Society)/ALAT (Latin America Thoracic Society) 2011 criteria within five years prior to consent.
- Men or non-pregnant, non-lactating women of non-childbearing potential.
- Age ≥ 40 years.
- Mild to moderate IPF as defined by predicted FVC ≥ 55% of normal and predicted DLCO > 40% of normal at Screening.
- Subjects receiving oral pirfenidone or nintedanib for treatment of IPF may participate if they have been on treatment with a stable, well-tolerated dose (as determined by the investigator), for at least 8 weeks prior to consent with no changes to therapy dose and schedule anticipated during the course of study participation.
- Must be able to understand a written informed consent, which must be obtained prior to any study procedures.
- Must be willing and able to comply with all study requirements
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) or allergy as judged by the investigator. Subjects with a history of seasonal rhinitis (hay fever) or childhood asthma may participate if these conditions are not active or expected to be active during the subject's participation.
- History of clinically significant cardiovascular, skin, renal, hepatic, respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization, or surgical procedure within 30 days prior to first dose of study drug. Subjects with a history of pancreatitis, heart failure, acute renal failure, bullous pemphigoid, or severe and disabling arthritis, conditions associated with postmarketing safety reports of oral gliptins, are excluded.
- Have poor venous access that limits phlebotomy.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin above upper limit of normal (elevated bilirubin in subject's with Gilbert Syndrome is allowed) or other clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody results.
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- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Appendix 1: CKD-EPI Equation).
- Subjects with a corrected QT interval by Fredericia (QTcF) of >450 msec at screening or first admission.
- Positive highly sensitive serum pregnancy test at screening or highly sensitive urine pregnancy test at first admission. Those who are pregnant or lactating will be excluded.
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer).
- Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2.
- Subjects who have taken, any over-the-counter drug or herbal remedies in the 15 days prior to first IMP administration. Subjects taking prescribed medication in the 90 days prior to first IMP administration. Subjects taking up to 4 g per day of acetaminophen may participate if discontinued at least 15 days prior to first IMP administration. Subjects taking DPP4 inhibitors are prohibited. Subjects taking strong CYP3A inhibitors are prohibited.
- History of any substance use disorder or alcohol use disorder in the past 2 years, as based on the diagnostic criteria in the Diagnostic and Statistical Manual Fifth Edition (DSM-5).
- Regular alcohol consumption in men >21 units per week and women >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
- A confirmed positive alcohol breath test at screening or first admission.
- Current smokers and those who have a smoking history of ≥ 10 pack-years. A confirmed positive urine cotinine test at screening or first admission.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- Positive test result for common drugs of abuse on screening and first admission.
- Men with pregnant or lactating partners.
- Donation of a unit of blood (about 500 mL) within 2 months or donation of plasma within 7 days prior to first dose of study medication.
- Subjects who are, or are immediate family members of, a study site or Sponsor employee.
- Active respiratory infection requiring treatment with antibiotics within 4 weeks prior to signing of ICF.
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
- Clinically significant deterioration between screening and Day 1.
- Use of any investigational drugs within 30 days or 5 half-lives prior to consent, whichever is longer.
- Serious adverse reaction or serious hypersensitivity to any DPP4 inhibitor (e.g., saxagliptin, sitagliptin) or the formulation excipients.
- Use of supplemental oxygen for resting hypoxemia.
- Evidence of significant renal impairment at screening, defined in this protocol as an estimated creatinine clearance (CLcr) of <50 mL/min using the CKD-EPI equation. Patients with renal insufficiency Clcr ≥ 50 mL/min with stable renal function (per clinical discretion, recommend based on average documented clinical chemistry values for at least 6 months) may participate.
- History of clinically significant and uncontrolled medical illness or clinically significant abnormal clinical chemistry, hematology, or urinalysis that represents a meaningful risk to the subject during this trial, as judged by the Investigator (e.g., heart failure).
- Subjects with a corrected QT interval by Fredericia (QTcF) of >450 msec at screening.
- Life expectancy < one year.
- Subject listed for lung transplant.
- Hospitalization or serious illness (as determined by the investigator) within the 3 months prior to consent.
- Alternative diagnoses that could lead to pulmonary fibrosis such as exposure to drugs, radiation, asbestos.
- Connective tissue disease that can lead to pulmonary fibrosis such as scleroderma or rheumatoid arthritis.
- Presence of clinically active, medically diagnosed asthma, chronic obstructive pulmonary disease, or active infection.
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
- History of severe hepatic impairment or AST or ALT greater than 3 times the upper limit of normal at screening.
- The use of required concomitant medications that represents a significant risk to produce an adverse drug interaction with CMR316, assessed by the investigator (in consultation with sponsor and sponsor's medical monitor). Specifically, subjects with Type 1 and Type 2 diabetes are excluded.
- Smoking within a year prior to consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Hanover, 30625
About this study
Official title: A Phase 1/1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF).
Read the detailed description
This is a 3-part, single-center study; Part 1 will evaluate single ascending doses (SAD) and Part 2 will evaluate multiple ascending doses (MAD; once weekly dosing for 4 weeks) of nebulized CMR316 or placebo in healthy male and female subjects. Part 3 will assess multiple doses (once weekly dosing for 5 weeks) of nebulized CMR316 (open-label) in subjects with IPF.
- Conditions
- Pulmonary Fibroses, Idiopathic
- Being tested
- CMR316, Placebo
- Keywords
- Pulmonary, IPF, Inhaled therapy
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR316Drug
CMR316 administered via nebulization at single or multiple dose(s) assigned by cohort
PlaceboDrug
Placebo administered via nebulization at single or multiple dose(s) to match CMR316 administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD CMR316 | Active comparator | Single ascending dose, nebulized administration of CMR316 Receives: Drug: CMR316 |
| Part 1 SAD Placebo | Placebo comparator | Single ascending dose, nebulized administration of matching placebo Receives: Drug: Placebo |
| Part 2 MAD CMR316 | Active comparator | Multiple ascending dose, nebulized administration of CMR316 once weekly for 4 weeks Receives: Drug: CMR316 |
| Part 2 MAD Placebo | Placebo comparator | Multiple ascending dose, nebulized administration of matching placebo once weekly for 4 weeks Receives: Drug: Placebo |
| Part 3 IPF Patients | Experimental | Open-label, nebulized administration of CMR316 once weekly for 5 weeks for patients with IPF Receives: Drug: CMR316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Adverse events will be analyzed for severity and potential relationship to CMR316 to determine safety and tolerability of CMR316
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Number of participants with clinically significant abnormal physical exam and vital signs
Vital signs will include evaluation of systolic and/or diastolic blood pressure (mmHg), heart rate (beats/min), temperature (Celsius), and respiratory rate (breaths/minute).
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Number of patients with reduced pulmonary function
Pulse oximeter will analyze oxygen saturation, spirometry will include evaluation of FEV1, FVC, and FEV1/FVC, and DLCO
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Number of participants with abnormal electrocardiogram readings
Electrocardiogram will include an evaluation of QTcF interval, ventricular rate, PR interval, QRS duration and QRS axis
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Number of participants with clinically significant abnormal laboratory test results
Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of CMR316
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Secondary outcomes (3)
Assess pharmacokinetics, AUC, as available
Area under the concentration-time curve (AUC) from time of administration
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Assess pharmacokinetics, Cmax, as available
Maximum drug concentration observed
Measured: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Assess pharmacodynamics, characterize enzymatic activity
Change from pre-dose baseline and % inhibition in enzymatic activity
Measured: Part 1: Day 1 though Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Aug 2024
- Primary completion23 Jun 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Fibroses, IdiopathicStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 Cohorts 1-4: double-blind, assess single ascending doses (SAD) of nebulized CMR316. Cohort 5: open label, single dose (at a dose previously determined to be safe) \& incl. lung sample collection via bronchoscopy for PK \& PD. Part 2: double blind, assess multiple ascending dose (MAD) cohorts of CMR316 administered once weekly for 4 weeks. If further PK/PD data from lung samples is required to determine appropriate RP2D then a sub-group of open-label participants who will undergo bronchoscopies may be enrolled to any or all MAD cohorts. Parts 1 \&2 are not required to be conducted entirely sequentially if justified by PK \& safety obtained. The first MAD cohort will not start until data are available from SAD Cohort 3 \& dosing for each MAD cohort will not exceed a dose level previously deemed safe in a SAD cohort. Part 3: IPF patients, will not start until data are available and reviewed from Parts 1 \& 2 and will not exceed a dose level previously deemed safe in a SAD/MAD cohort.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Calibr Chief Medical Officer, Principal investigator, Calibr-Skaggs Institute for Innovative Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589219
- Sponsor's protocol ID
- CBR-CMR316-3001
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06589219
- Acronym / sponsor ID
- CBR-CMR316-3001
- Conditions
- Pulmonary Fibroses, Idiopathic
- Keywords
- Pulmonary, IPF, Inhaled therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 19 Sep 2024 (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 purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF).
Detailed description
This is a 3-part, single-center study; Part 1 will evaluate single ascending doses (SAD) and Part 2 will evaluate multiple ascending doses (MAD; once weekly dosing for 4 weeks) of nebulized CMR316 or placebo in healthy male and female subjects. Part 3 will assess multiple doses (once weekly dosing for 5 weeks) of nebulized CMR316 (open-label) in subjects with IPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part 1 Cohorts 1-4: double-blind, assess single ascending doses (SAD) of nebulized CMR316. Cohort 5: open label, single dose (at a dose previously determined to be safe) \& incl. lung sample collection via bronchoscopy for PK \& PD. Part 2: double blind, assess multiple ascending dose (MAD) cohorts of CMR316 administered once weekly for 4 weeks. If further PK/PD data from lung samples is required to determine appropriate RP2D then a sub-group of open-label participants who will undergo bronchoscopies may be enrolled to any or all MAD cohorts. Parts 1 \&2 are not required to be conducted entirely sequentially if justified by PK \& safety obtained. The first MAD cohort will not start until data are available from SAD Cohort 3 \& dosing for each MAD cohort will not exceed a dose level previously deemed safe in a SAD cohort. Part 3: IPF patients, will not start until data are available and reviewed from Parts 1 \& 2 and will not exceed a dose level previously deemed safe in a SAD/MAD cohort.
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD CMR316 | Active comparator | Drug: CMR316Single ascending dose, nebulized administration of CMR316 |
| Part 1 SAD Placebo | Placebo comparator | Drug: PlaceboSingle ascending dose, nebulized administration of matching placebo |
| Part 2 MAD CMR316 | Active comparator | Drug: CMR316Multiple ascending dose, nebulized administration of CMR316 once weekly for 4 weeks |
| Part 2 MAD Placebo | Placebo comparator | Drug: PlaceboMultiple ascending dose, nebulized administration of matching placebo once weekly for 4 weeks |
| Part 3 IPF Patients | Experimental | Drug: CMR316Open-label, nebulized administration of CMR316 once weekly for 5 weeks for patients with IPF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential, 18-60 years of age.
- Must agree to use a highly effective method of contraception.
- Body Mass Index (BMI) 18-33 kg/m2 as measured at screening.
- Weight ≤100 kg at screening.
- Normal lung function, defined as: FVC and FEV1 > 80% predicted (based on age, height, race, sex, SaO2 > 95% on room air.
Key exclusion criteria (40 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) or allergy as judged by the investigator. Subjects with a history of seasonal rhinitis (hay fever) or childhood asthma may participate if these conditions are not active or expected to be active during the subject's participation.
- History of clinically significant cardiovascular, skin, renal, hepatic, respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization, or surgical procedure within 30 days prior to first dose of study drug. Subjects with a history of pancreatitis, heart failure, acute renal failure, bullous pemphigoid, or severe and disabling arthritis, conditions associated with postmarketing safety reports of oral gliptins, are excluded.
- Have poor venous access that limits phlebotomy.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin above upper limit of normal (elevated bilirubin in subject's with Gilbert Syndrome is allowed) or other clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
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 |
|---|---|---|
| CMR316CMR316 administered via nebulization at single or multiple dose(s) assigned by cohort | Drug | Part 1 SAD CMR316, Part 2 MAD CMR316, Part 3 IPF Patients |
| PlaceboPlacebo administered via nebulization at single or multiple dose(s) to match CMR316 administration | Drug | Part 1 SAD Placebo, Part 2 MAD Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Adverse events will be analyzed for severity and potential relationship to CMR316 to determine safety and tolerability of CMR316
Number of participants with clinically significant abnormal physical exam and vital signs
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Vital signs will include evaluation of systolic and/or diastolic blood pressure (mmHg), heart rate (beats/min), temperature (Celsius), and respiratory rate (breaths/minute).
Number of patients with reduced pulmonary function
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Pulse oximeter will analyze oxygen saturation, spirometry will include evaluation of FEV1, FVC, and FEV1/FVC, and DLCO
Number of participants with abnormal electrocardiogram readings
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Electrocardiogram will include an evaluation of QTcF interval, ventricular rate, PR interval, QRS duration and QRS axis
Number of participants with clinically significant abnormal laboratory test results
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of CMR316
3 secondary outcomes
Assess pharmacokinetics, AUC, as available
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Assess pharmacokinetics, Cmax, as available
Time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Assess pharmacodynamics, characterize enzymatic activity
Time frame: Part 1: Day 1 though Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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. This study is not recruiting at the moment.
Calibr Chief Medical Officer principal investigator
Calibr-Skaggs Institute for Innovative Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMR316 in people with Pulmonary Fibroses, Idiopathic, run by Calibr, a division of Scripps Research at 1 site in Germany.
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 14 inclusion and 40 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: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Part 1: Day 1 through Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50). The study lists 5 primary outcomes in all. 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 9 Jul 2026.