A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).

Study Identifier:
CLI-10067AA1-01
ClinicalTrials.gov Identifier:
NCT05513950
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan
Available Languages: English
Download document(s)

Study Details

Medical Condition
  • Idiopatic Pulmonary Fibrosis
Study Drug
  • Biological: CHF10067 starting dose -- 1000mg (Cohort A)
  • Biological: CHF10067 intermediate dose -- 2000mg (Cohort B)
  • Biological: CHF10067 high dose -- 3000mg (Cohort C)
  • Drug: Placebo
Date
Jan 2023 - Jun 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
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/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines. Diagnosis of IPF must be within the past 5 years prior to enrolment, and in the opinion of the Investigator, has been stable for at least 3 months.
  • Subjects not receiving any IPF treatment (including subjects with previous use of antifibrotic treatment that has been stopped for at least 2 weeks prior to screening) or receiving well-tolerated standard of care approved treatments at a stable dose for at least 8 weeks prior to screening (nintedanib or pirfenidone) and it is anticipated the dose will remain unchanged throughout the study.
  • Forced vital capacity (FVC) ≥ 50% of predicted and ratio of forced expiratory volume in 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 study protocol.
Exclusion Criteria
  • History of lower respiratory tract infection within 4 weeks prior to screening and up to Day 1 of the study.
  • History of acute exacerbation of IPF within 3 months prior to screening and up to Day 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 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
  • Infiltrative lung disease other than IPF
  • Subjects exhibiting unhealed wounds or foot ulcers or have known history of wound healing complications.
  • Chronic heart failure categorized as New York Heart Association Class II, III, or IV; clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary hypertension
  • Currently receiving, or have received, a systemic corticosteroid, immunosuppressant, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved or investigational treatment for IPF within 4 weeks prior to screening or prior to randomization.
  • Coronavirus disease-2019 (COVID-19) vaccine at least 7 days before dosing. Any systemic symptoms (e.g. myalgia, fever, chills, fatigue, etc.) after COVID-19 vaccine should subside at least 2 days before the Day 1 visit.
  • Documented COVID-19 diagnosis within the last 4 weeks or which has not resolved within 7 days prior to screening or before treatment.
  • Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation 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 clinical investigation or which may impact the safety of the subject or the evaluation of the study results according to Investigator judgement. .
  • Pregnant or lactating women.
Healthy Volunteers
No

Protocol Summary

Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it. The body's immune response to the study drug was evaluated.

Chiesi conducted this study in patients affected by idiopathic pulmonary fibrosis (IPF, a progressive and chronic lung disease). Chiesi performed this study to establish the drug doses that would be suitable for future studies (a dose finding study).

Study Locations

Location
Status
Location
PHI University Clinic of Pulmonology and Allergology
Skopje, Unmapped, 1000
Status
N/A
Location
Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials
Kyiv, Ukraine, 01135
Status
N/A
Location
Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Status
N/A
Location
Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus
Cambridge, United Kingdom, CB2 0AY
Status
N/A
Location
University of Dundee, NHS Tayside - Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Status
N/A
Location
Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,
Edinburgh, United Kingdom, EH16 4SA
Status
N/A
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