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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 patients affected by idiopathic pulmonary fibrosis (IPF, a
lung disease).
Chiesi is doing this study to establish the doses suitable for future studies.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
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.
Interventional
Eligible Ages
40 Years and Over
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 ≥ 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.
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.
Industry
Overall Status
Recruiting
Countries
North Macedonia, Ukraine, United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Additional Details
The principal aim of this study is to obtain safety and tolerability data when CHF10067 is
administered intravenously as single ascending doses to subjects with IPF. This information,
together with the pharmacokinetic (PK) and immunogenicity data, will help establish the doses
suitable for future studies in subjects. The effect of CHF10067 on TG2 levels will also be
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 will be used so that in each cohort 2
subjects (1 CHF10067 and 1 placebo) will be dosed at least 24 hours before the remaining 6
subjects.
The study will be double-blind and placebo-controlled to avoid bias in the collection and
evaluation of data during its conduct. Placebo has been chosen as the comparison treatment to
assess whether any observed effects are treatment-related or simply reflect the study
conditions.
Arms & Interventions
Arms
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)
Interventions
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
Skopje, North Macedonia
Status
Recruiting
Address
PHI University Clinic of Pulmonology and Allergology