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

NCT05513950 | Completed Phase 1 Results DMC

• 1 other identifier: CLI-10067AA1-01
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 9

Brief 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).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs

  Evaluate reported adverse events (AEs) and serious adverse events (SAEs). The number of subjects affected by AEs or SAEs is presented below. Please note: comprehensive summaries of AEs and SAEs are presented in section 'Adverse Events'; these include the preferred term of the AE or SAE, the number of subjects affected, and the number of events for a each preferred term.

  From pre-dose (baseline) up to day 84.

Secondary Outcomes (13)

• 2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)]

  Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose.

• 3_Area Under the Concentration-time Curve (AUC) From Zero to Infinity (AUC0-∞)

  Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose.

• 4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax)

  Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose.

• 5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax)

  Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion, 2, 4, 8, and 20 h after the end of infusion and 5, 7, 14, 28, 56, and 84 days post-dose.

• 6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf)

  Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).

Study Arms (2)

Test Treatment

EXPERIMENTAL

A single intravenous (IV) dose of CHF10067

Biological: CHF10067 starting dose -- 1000mg (Cohort A); Biological: CHF10067 intermediate dose -- 2000mg (Cohort B); Biological: CHF10067 high dose -- 3000mg (Cohort C)

Reference treatment

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CHF10067 starting dose -- 1000mg (Cohort A) BIOLOGICAL

Intravenous administration of a starting dose of the monoclonal antibody

Test Treatment

CHF10067 intermediate dose -- 2000mg (Cohort B) BIOLOGICAL

Intravenous administration of an intermediate dose of the monoclonal antibody

Test Treatment

CHF10067 high dose -- 3000mg (Cohort C) BIOLOGICAL

Intravenous administration of a high dose of the monoclonal antibody

Test Treatment

Placebo DRUG

Intravenous administration of a physiological solution as placebo

Reference treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (9)

PHI University Clinic of Pulmonology and Allergology

Skopje, 1000, North Macedonia

Location

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

Kyiv, 01135, Ukraine

Location

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

Birmingham, B15 2TH, United Kingdom

Location

Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus

Cambridge, CB2 0AY, United Kingdom

Location

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

Dundee, DD1 9SY, United Kingdom

Location

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

Edinburgh, EH16 4SA, United Kingdom

Location

Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

Medicines Evaluation Unit - The Langley Building

Manchester, M23 9QZ, United Kingdom

Location

University Hospital Southampton - Department of Respiratory Medicine

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Lisa Spencer

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigational Medicinal Product (IMP) was blinded for the participant, investigators, and the sponsor. At the study site an unblinded pharmacist (or designee) prepared the IMP and an unblinded clinical research associate checked the documents of the IMP preparation.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with single dose escalation: 3 separate cohorts received 3 incremental doses of Investigational Medicinal Product (IMP). Each cohort started when the previous cohort was completed and the data were evaluated by the Safety Advisory Committee.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 24, 2022
• Study Start: January 25, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); NO (1); UA (1)