Learn about Research & Clinical Trials

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

Study Purpose

The purpose of this study is to assess the safety of CHF10067 (the study drug) and any side effects that might be associated with it. In addition, the study will evaluate 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 will also be evaluated. The study may also evaluate the effect of the study drug on the level of a certain protein in the body. Chiesi is conducting this study on people affected by idiopathic pulmonary fibrosis (IPF, a lung disease). The reason Chiesi is doing this study is to establish the doses suitable for future studies in subjects

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject's written informed consent obtained prior to any study-related procedure.
  • - Males or females, of any race, aged between 40 and 80 years of age, inclusive.
  • - 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) 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 and prior to randomization.
  • - Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 35% to 79% of predicted, inclusive at screening and prior to randomization.
  • - 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 respiratory tract infection within 2 months 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 8 weeks or which has not resolved within 14 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chiesi Farmaceutici S.p.A.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lisa Spencer
Principal Investigator Affiliation Liverpool University Hospitals NHS Foundation Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions


Experimental: Test Treatment

A single intravenous (IV) dose of CHF10067

Placebo Comparator: Reference treatment

A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)


Biological: - CHF10067 starting dose

Intravenous administration of a starting dose of the monoclonal antibody

Biological: - CHF10067 intermediate dose

Intravenous administration of an intermediate dose of the monoclonal antibody

Biological: - CHF10067 high dose

Intravenous administration of a high dose of the monoclonal antibody

Drug: - Placebo

Intravenous administration of a physiological solution as placebo.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Liverpool, United Kingdom




Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust

Liverpool, , L7 8XP

Site Contact

Lisa Spencer, MD


+ 39 0521 2791