Idiopathic Pulmonary FibrosisPhase 1NCT05513950
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
A Phase 1 study testing CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B) and CHF10067 high dose -- 3000mg (Cohort C) in people with Idiopathic Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A. at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B) and CHF10067 high dose -- 3000mg (Cohort C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 25 Jan 2023to 17 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United Kingdom7 sites
Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus
Cambridge, CB2 0AY
University of Dundee, NHS Tayside - Ninewells Hospital & Medical School
Dundee, DD1 9SY
Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,
Edinburgh, EH16 4SA
Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust
Liverpool, L7 8XP
Medicines Evaluation Unit - The Langley Building
Manchester, M23 9QZ
University Hospital Southampton - Department of Respiratory Medicine
Southampton
North Macedonia1 site
PHI University Clinic of Pulmonology and Allergology
Skopje, 1000
Ukraine1 site
Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials
Kyiv, 01135
About this study
Official title: A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Intravenous Monoclonal Antibody (mAb) After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis.
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).
Read the detailed 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C), Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF10067 starting dose -- 1000mg (Cohort A)Biological
Intravenous administration of a starting dose of the monoclonal antibody
CHF10067 intermediate dose -- 2000mg (Cohort B)Biological
Intravenous administration of an intermediate dose of the monoclonal antibody
CHF10067 high dose -- 3000mg (Cohort C)Biological
Intravenous administration of a high dose of the monoclonal antibody
PlaceboDrug
Intravenous administration of a physiological solution as placebo
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment | Experimental | A single intravenous (IV) dose of CHF10067 Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)]
Evaluate the area under the concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) of CHF10067 after a single dose.
Measured: 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-∞)
Evaluate the area under the concentration-time curve (AUC) from zero to infinity (AUC0-∞) of CHF10067 after a single dose.
Measured: 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)
Evaluate the Cmax (maximum observed concentration) after a single dose of CHF10067.
Measured: 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)
Evaluate the time to maximum observed concentration (tmax).
Measured: 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)
Evaluate serum concentration at the end of infusion (Cinf) of CHF10067.
Measured: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).
7_Pharmacokinetics -- Time at the End of Infusion (Tinf)
Evaluate the time of serum concentration at the end of infusion (Tinf). Time at the end of the infusion.
Measured: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).
8_Pharmacokinetics -- Clearance (CL)
Evaluate clearance (CL) of CHF10067.
Measured: 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.
9_Pharmacokinetics -- Volume of Distribution (Vz)
Evaluate volume of distribution (Vz) CHF10067.
Measured: 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.
10_Pharmacokinetics -- Terminal Half-life (t1/2)
Evaluate the terminal half-life (t1/2) of CHF10067.
Measured: From pre-dose (baseline) up to day 84.
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Forced expiratory volume in the first second (FEV1) parameters, summarised using descriptive statistics at each analysis time point by treatment.
Summary results show the change from baseline of the percent predicted.
Measured: Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Forced vital capacity (FVC) parameters will be summarised using descriptive statistics at each analysis time point by treatment.
Summary results show the change from baseline of the percent predicted.
Measured: Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Evaluate abnormal changes in systolic and diastolic blood pressure from baseline at any post-baseline time point.
Measured: From pre-dose (baseline) up to day 84.
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
Evaluate the immunogenicity profile of CHF 10067 in serum, with respect to the development of anti-drug antibody (ADA) and neutralising antibody (nAb).
A robust immunogenicity profile indicates the potential for the drug to trigger an immune response in patients, leading to the formation of ADAs. These antibodies can affect the drug's efficacy, safety, and pharmacokinetics.
Detecting the presence of ADAs in serum samples was performed using an enzyme linked immunosorbent assay (ELISA), a validated assay method. Neutralizing Antibody (nAb) are a subset of ADAs that can interfere with the drug's therapeutic activity by blocking its binding to the target or inhibiting its downstream effects. The presence of ADAs and nAbs can affect the drug's pharmacokinetics (PK) by altering its absorption, distribution, metabolism, and excretion. This can lead to changes in drug exposure and potentially impact efficacy and safety.
Measured: Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start25 Jan 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Spencer, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513950
- Sponsor's protocol ID
- CLI-10067AA1-01
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2022
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Intravenous Monoclonal Antibody (mAb) After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis.
- ClinicalTrials.gov ID
- NCT05513950
- Acronym / sponsor ID
- CLI-10067AA1-01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test Treatment | Experimental | Biological: CHF10067 starting dose -- 1000mg (Cohort A), Biological: CHF10067 intermediate dose -- 2000mg (Cohort B), Biological: CHF10067 high dose -- 3000mg (Cohort C)A single intravenous (IV) dose of CHF10067 |
| Reference treatment | Placebo comparator | Drug: PlaceboA single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF10067 starting dose -- 1000mg (Cohort A)Intravenous administration of a starting dose of the monoclonal antibody | Biological | Test Treatment |
| CHF10067 intermediate dose -- 2000mg (Cohort B)Intravenous administration of an intermediate dose of the monoclonal antibody | Biological | Test Treatment |
| CHF10067 high dose -- 3000mg (Cohort C)Intravenous administration of a high dose of the monoclonal antibody | Biological | Test Treatment |
| PlaceboIntravenous administration of a physiological solution as placebo | Drug | Reference treatment |
Primary outcome
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
Time frame: From pre-dose (baseline) up to day 84.
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.
13 secondary outcomes
2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)]
Time frame: 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-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).
7_Pharmacokinetics -- Time at the End of Infusion (Tinf)
Time frame: Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).
8_Pharmacokinetics -- Clearance (CL)
Time frame: 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.
9_Pharmacokinetics -- Volume of Distribution (Vz)
Time frame: 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.
10_Pharmacokinetics -- Terminal Half-life (t1/2)
Time frame: From pre-dose (baseline) up to day 84.
11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
Time frame: Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
Time frame: Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Time frame: From pre-dose (baseline) up to day 84.
14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
Time frame: Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Spencer principal investigator
Liverpool University Hospitals NHS Foundation Trust
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B) and CHF10067 high dose -- 3000mg (Cohort C) in people with Idiopathic Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, North Macedonia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs (time frame: From pre-dose (baseline) up to day 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.