Trials Sponsors Conditions Drugs Pricing

Conditions

Idiopathic Pulmonary Fibrosis Pulmonary Fibroses, Idiopathic

Keywords

PulmonaryIPFInhaled therapy

Outcome Measures

Primary Outcomes (5)

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
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).
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
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
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
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
Part 1: Day 1 though Day 15; Part 2: Day 1 through Day 36; Part 3: Day 1 through Day 50

Study Arms (5)

Part 1 SAD CMR316

ACTIVE COMPARATOR

Single ascending dose, nebulized administration of CMR316

Drug: CMR316

Part 1 SAD Placebo

PLACEBO COMPARATOR

Single ascending dose, nebulized administration of matching placebo

Drug: Placebo

Part 2 MAD CMR316

ACTIVE COMPARATOR

Multiple ascending dose, nebulized administration of CMR316 once weekly for 4 weeks

Drug: CMR316

Interventions

CMR316Drug

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

Part 1 SAD CMR316Part 2 MAD CMR316Part 3 IPF Patients

PlaceboDrug

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

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

The Scripps Research Institute
Otherlead
Calibr, a division of Scripps Research
Otherlead

Study Sites (1)

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Hanover, 30625, Germany

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

Calibr Chief Medical Officer
Calibr-Skaggs Institute for Innovative Medicines
PRINCIPAL INVESTIGATOR

Enrollment

89 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: The majority of this study will be conducted double-blind; treatment assignment will not be known to the subjects, the Sponsor (with exception of an unblinded bioanalytical specialist who will review PK and PD and blind data for presentation to blinded team) and staff involved in the clinical evaluation of the subjects and the analysis of data. The randomization schedule and disclosure envelopes will be generated by an unblinded statistical team. The unblinded statistical team will not be involved in decisions relating to populations for analysis prior to unblinding. Prior to database lock and unblinding, all original randomization materials will be held by the unblinded statistical team. There may be instances where interim data has the potential to reveal treatment. In these cases, every effort will be made by the unblinded bioanalytical specialist to maintain blinding by appropriate presentation of data to the study team.
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

You may not qualify if:

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.
+25 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (3)

Study Arms (5)

Part 1 SAD CMR316

Part 1 SAD Placebo

Part 2 MAD CMR316

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Part 2 MAD Placebo

Part 3 IPF Patients

You may not qualify if:

Study Record Dates

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (3)

Study Arms (5)

Part 1 SAD CMR316

Part 1 SAD Placebo

Part 2 MAD CMR316

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Part 2 MAD Placebo

Part 3 IPF Patients

You may not qualify if:

Study Record Dates

Data Sharing

Source records

Locations