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

Last updated: July 28, 2025
Sponsor: Chiesi Farmaceutici S.p.A.
Overall Status: Completed

Phase

1

Condition

Scar Tissue

Lung Injury

Lung Disease

Treatment

CHF10067 starting dose

CHF10067 high dose

CHF10067 starting dose -- 1000mg (Cohort A)

Clinical Study ID

NCT05513950
CLI-10067AA1-01
  • Ages > 40
  • All Genders

Study 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).

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

Total Participants: 52
Treatment Group(s): 7
Primary Treatment: CHF10067 starting dose
Phase: 1
Study Start date:
January 25, 2023
Estimated Completion Date:
June 17, 2024

Study Description

The principal aim of this study was to obtain safety and tolerability data when CHF10067 was administered intravenously as single ascending doses to subjects with IPF (a progressive and chronic lung disease). This information, together with the pharmacokinetic (PK) and immunogenicity data is part of a dose finding efforts, for future clinical studies. The effect of CHF10067 on transglutaminase 2 (TG2) levels was also investigated as an exploratory endpoint.

A sequential group, single ascending dose design has been chosen for safety reasons because CHF10067 is in the early stages of clinical development and no data in the IPF population has been collected so far. In addition, sentinel dosing was used so that in each cohort 2 subjects (1 CHF10067 and 1 placebo) was administered at least 24 hours, before the remaining 6 subjects.

The study was double-blind and placebo-controlled to avoid bias in the collection and evaluation of data during its conduct. Placebo was chosen as the comparison treatment to assess whether any observed effects are treatment-related or reflect the study conditions.

Connect with a study center

  • PHI University Clinic of Pulmonology and Allergology

    Skopje, 1000
    North Macedonia

    Site Not Available

  • Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials

    Kyiv, 01135
    Ukraine

    Site Not Available

  • Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • University of Dundee, NHS Tayside - Ninewells Hospital & Medical School

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,

    Edinburgh, EH16 4SA
    United Kingdom

    Site Not Available

  • Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Medicines Evaluation Unit - The Langley Building

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • University Hospital Southampton - Department of Respiratory Medicine

    Southampton,
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.