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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis

A Phase 1/1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis

Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis (NCT06589219) is a Phase 1 interventional studying Pulmonary Fibroses, Idiopathic, sponsored by Calibr, a division of Scripps Research. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pulmonary Fibroses, Idiopathic, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 106 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pulmonary Fibroses, Idiopathic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Part 1 \& 2 - 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). - 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. Who May Qualify: Part 3 - 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 willing to sign a consent form, which must be obtained prior to any study procedures. - Must be willing and able to comply with all study requirements Who Should NOT Join This Trial: Part 1 \& 2 - Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Part 1 \& 2 * 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). * 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. Inclusion Criteria: Part 3 * 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 Exclusion Criteria: Part 1 \& 2 * 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. * 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. Exclusion Criteria: Part 3 * 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.

Treatments Being Tested

DRUG

CMR316

CMR316 administered via nebulization at single or multiple dose(s) assigned by cohort

DRUG

Placebo

Placebo administered via nebulization at single or multiple dose(s) to match CMR316 administration

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Hanover, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06589219), the sponsor (Calibr, a division of Scripps Research), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06589219 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06589219?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06589219?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06589219. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06589219. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.