Phase
Condition
Scar Tissue
Lung Injury
Lung Disease
Treatment
CHF10067 starting dose
CHF10067 high dose
CHF10067 starting dose -- 1000mg (Cohort A)
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject's written informed consent obtained prior to any study-related procedure.
Males or females, of any race, aged ≥ 40 years of age.
Body weight ≥ 45 kg.
Diagnosis of IPF as defined by current American Thoracic Society/EuropeanRespiratory Society/Japanese Respiratory Society/Latin American Thoracic Associationguidelines. Diagnosis of IPF must be within the past 5 years prior to enrolment, andin the opinion of the Investigator, has been stable for at least 3 months.
Subjects not receiving any IPF treatment (including subjects with previous use ofantifibrotic treatment that has been stopped for at least 2 weeks prior toscreening) or receiving well-tolerated standard of care approved treatments at astable dose for at least 8 weeks prior to screening (nintedanib or pirfenidone) andit is anticipated the dose will remain unchanged throughout the study.
Forced vital capacity (FVC) ≥ 50% of predicted and ratio of forced expiratory volumein the first second (FEV1)/FVC ≥ 0.7 at screening.
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) ≥ 35% at screening.
Able to understand the study procedures and the risks involved.
Male and Female subjects following contraceptive requirements detailed in the studyprotocol.
Exclusion
Exclusion Criteria:
History of lower respiratory tract infection within 4 weeks prior to screening andup to Day 1 of the study.
History of acute exacerbation of IPF within 3 months prior to screening and up toDay 1 of the study
Active diagnosis of lung cancer or a history of lung cancer.
Active cancer or a history of cancer (other than lung cancer) with less than 5 yearsdisease free survival time (whether or not there is evidence of local recurrence ormetastases).
Infiltrative lung disease other than IPF
Subjects exhibiting unhealed wounds or foot ulcers or have known history of woundhealing complications.
Chronic heart failure categorized as New York Heart Association Class II, III, orIV; clinical diagnosis of cor pulmonale requiring specific treatment; or severepulmonary hypertension
Currently receiving, or have received, a systemic corticosteroid, immunosuppressant,cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved orinvestigational treatment for IPF within 4 weeks prior to screening or prior torandomization.
Coronavirus disease-2019 (COVID-19) vaccine at least 7 days before dosing. Anysystemic symptoms (e.g. myalgia, fever, chills, fatigue, etc.) after COVID-19vaccine should subside at least 2 days before the Day 1 visit.
Documented COVID-19 diagnosis within the last 4 weeks or which has not resolvedwithin 7 days prior to screening or before treatment.
Known intolerance and/or hypersensitivity to any of the excipients contained in theformulation or any other substance used in the study.
History of allergic or anaphylactic reaction to human, humanised, chimeric,immunoglobulins (Igs), or murine monoclonal antibodies.
Clinically relevant abnormal laboratory values (clinical chemistry and haematology)at screening suggesting an unknown disease and requiring further clinicalinvestigation or which may impact the safety of the subject or the evaluation of thestudy results according to Investigator judgement. .
Pregnant or lactating women.
Study Design
Study Description
Connect with a study center
PHI University Clinic of Pulmonology and Allergology
Skopje, 1000
North MacedoniaSite Not Available
Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials
Kyiv, 01135
UkraineSite Not Available
Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomSite Not Available
Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus
Cambridge, CB2 0AY
United KingdomSite Not Available
University of Dundee, NHS Tayside - Ninewells Hospital & Medical School
Dundee, DD1 9SY
United KingdomSite Not Available
Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,
Edinburgh, EH16 4SA
United KingdomSite Not Available
Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust
Liverpool, L7 8XP
United KingdomSite Not Available
Medicines Evaluation Unit - The Langley Building
Manchester, M23 9QZ
United KingdomSite Not Available
University Hospital Southampton - Department of Respiratory Medicine
Southampton,
United KingdomSite Not Available

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