CompletedNCT05513950Updated Aug 14, 2025Results posted

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

A Phase 1 interventional study of CHF10067 starting dose -- 1000mg (Cohort A) and CHF10067 intermediate dose -- 2000mg (Cohort B) in Idiopathic Pulmonary Fibrosis, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 9 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 52
Allocation: Randomized
Ages: 40 Years and older
Sex: All

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).

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 studied

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis 551

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's enrollment of 52 is close to the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 52 participants (actual)

Study arms

Experimental
Test Treatment
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)
Placebo comparator
Reference treatment
A single dose of placebo (commercial source of 0.9% sodium chloride aqueous solution)
Drug: Placebo

Interventions

BiologicalCHF10067 starting dose -- 1000mg (Cohort A)
Intravenous administration of a starting dose of the monoclonal antibody
BiologicalCHF10067 intermediate dose -- 2000mg (Cohort B)
Intravenous administration of an intermediate dose of the monoclonal antibody
BiologicalCHF10067 high dose -- 3000mg (Cohort C)
Intravenous administration of a high dose of the monoclonal antibody
DrugPlacebo
Intravenous administration of a physiological solution as placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
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-∞)
Evaluate the area under the concentration-time curve (AUC) from zero to infinity (AUC0-∞) of CHF10067 after a single dose.
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)
Evaluate the Cmax (maximum observed concentration) after a single dose of CHF10067.
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)
Evaluate the 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)
Evaluate serum concentration at the end of infusion (Cinf) of CHF10067.
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)
Evaluate the time of serum concentration at the end of infusion (Tinf). Time at the end of the infusion.
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)
Evaluate clearance (CL) of CHF10067.
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)
Evaluate volume of distribution (Vz) CHF10067.
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)
Evaluate the terminal half-life (t1/2) of CHF10067.
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
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.
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
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.
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
Evaluate abnormal changes in systolic and diastolic blood pressure from baseline at any post-baseline time point.
Time frame: 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.
Time frame: Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination.

Results

Posted Aug 14, 2025

Participant flow

For the study, 52 male and female subjects were screened 3-28 days before randomization; of these, 27 subjects were screening failures. Overall, 25 subjects were randomized; of these 1 subject (CHF 10067 3000 mg) did not receive the study medication due to technical reasons.

Participant flow — Overall Study
Milestone	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Started	6	6	7	6
Completed	6	6	6	6
Not completed	0	0	1	0
Withdrew: Not treated due to technical reasons	0	0	1	0

Outcome measures

Primary1_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.

Time frame:: From pre-dose (baseline) up to day 84.
Reported as:: Count of participants · Participants

1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs
Participants	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Serious TEAE	0	0	1	0
Non-serious TEAE	4	3	5	4
AE leading to study treatment discontinuation	0	0	0	0
AE leading to death	0	0	0	0

Secondary2_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.

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.
Reported as:: Mean · day.μg/mL

2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)]
day.μg/mL	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
2_Systemic Exposure [Area Under the Concentration-time Curve From Zero to Time (AUC0-t)]	3424 ± 647	7902 ± 1001	15592 ± 3027

Secondary3_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.

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.
Reported as:: Mean · day.μg/mL

3_Area Under the Concentration-time Curve (AUC) From Zero to Infinity (AUC0-∞)
day.μg/mL	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
3_Area Under the Concentration-time Curve (AUC) From Zero to Infinity (AUC0-∞)	3450 ± 660	8141 ± 1112	16328 ± 3245

Secondary4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax)

Evaluate the Cmax (maximum observed concentration) after a single dose of CHF10067.

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.
Reported as:: Mean · μg/mL

4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax)
μg/mL	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax)	307 ± 43.9	668 ± 126	1067 ± 173

Secondary5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax)

Evaluate the 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.
Reported as:: Median · hour

5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax)
hour	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax)	1.69 (1.67 to 3.67)	3.78 (3.58 to 11.67)	5.39 (5.35 to 7.43)

Secondary6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf)

Evaluate serum concentration at the end of infusion (Cinf) of CHF10067.

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).
Reported as:: Mean · μg/mL

6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf)
μg/mL	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf)	304 ± 44.6	658 ± 138	1065 ± 174

Secondary7_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.

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).
Reported as:: Median · hour

7_Pharmacokinetics -- Time at the End of Infusion (Tinf)
hour	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
7_Pharmacokinetics -- Time at the End of Infusion (Tinf)	1.68 (1.67 to 1.72)	3.69 (3.58 to 3.85)	5.38 (5.35 to 5.50)

Secondary8_Pharmacokinetics -- Clearance (CL)

Evaluate clearance (CL) of CHF10067.

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.
Reported as:: Mean · liter/day

8_Pharmacokinetics -- Clearance (CL)
liter/day	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
8_Pharmacokinetics -- Clearance (CL)	0.295 ± 0.0489	0.250 ± 0.0357	0.190 ± 0.0363

Secondary9_Pharmacokinetics -- Volume of Distribution (Vz)

Evaluate volume of distribution (Vz) CHF10067.

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.
Reported as:: Mean · liter

9_Pharmacokinetics -- Volume of Distribution (Vz)
liter	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
9_Pharmacokinetics -- Volume of Distribution (Vz)	4.93 ± 0.969	5.99 ± 0.716	5.21 ± 1.03

Secondary10_Pharmacokinetics -- Terminal Half-life (t1/2)

Evaluate the terminal half-life (t1/2) of CHF10067.

Time frame:: From pre-dose (baseline) up to day 84.
Reported as:: Mean · days

10_Pharmacokinetics -- Terminal Half-life (t1/2)
days	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)
10_Pharmacokinetics -- Terminal Half-life (t1/2)	11.7 ± 2.20	16.8 ± 2.32	19.1 ± 1.93

Secondary11_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.

Time frame:: Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
Reported as:: Mean · percent predicted FEV1

11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline
percent predicted FEV1	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Day 7	3.93 ± 3.35	0.50 ± 2.74	-0.20 ± 1.34	-0.43 ± 2.60
Day 28	3.76 ± 3.66	-0.55 ± 3.06	-2.93 ± 2.81	-0.55 ± 3.37
Day 56	3.18 ± 3.58	-0.68 ± 3.54	-0.75 ± 5.68	-1.35 ± 2.93
Day 84	0.13 ± 5.57	0.36 ± 4.30	-2.70 ± 2.93	-1.40 ± 3.62

Secondary12_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.

Time frame:: Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.
Reported as:: Mean · percent predicted FVC

12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline
percent predicted FVC	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Day 7	3.12 ± 2.24	-0.90 ± 3.31	-0.50 ± 2.89	-0.92 ± 3.80
Day 28	2.70 ± 3.74	-0.50 ± 2.58	-3.23 ± 2.76	-0.13 ± 4.10
Day 56	2.50 ± 1.87	-1.17 ± 3.12	-1.42 ± 6.55	-0.90 ± 2.84
Day 84	-0.72 ± 4.02	-0.36 ± 3.56	-1.98 ± 3.79	-1.97 ± 3.22

Secondary13_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.

Time frame:: From pre-dose (baseline) up to day 84.
Reported as:: Count of participants · Participants

13_Vital Signs -- Abnormal Changes in Systolic and Diastolic Blood Pressure
Participants	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Systolic Blood Pressure Decrease From Baseline >20 mmHg	3	0	1	2
Systolic Blood Pressure Increase From Baseline >20 mmHg	1	0	1	2
Diastolic Blood Pressure Decrease From Baseline >10 mmHg	3	5	5	4
Diastolic Blood Pressure Increase From Baseline >10 mmHg	2	2	2	3

Secondary14_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.

Time frame:: Pre-dose (baseline), at day 14, 28, 56, 84, and in case of early termination.
Reported as:: Count of participants · Participants

14_Immunogenicity Profile -- Anti-drug Antibody (ADA) and Neutralising Antibody (nAb).
Participants	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
1_Baseline ADA positive	0	0	0	0
2_ADA prevalence	1	0	0	0
3_ADA incidence (ADA+)	1	0	0	0
4_Duration of ADA Persistently positive ADA	0	0	0	0
5_Duration of ADA Transiently positive ADA	1	0	0	0
6_Treatment-boosted ADA	0	0	0	0
7_nAb positive at any visit	1	0	0	0

Adverse events

Collected over Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CHF 10067 1000 mg (Test Treatment)	0/6 (0%)	0/6 (0%)	4/6 (66.7%)
CHF 10067 2000 mg (Test Treatment)	0/6 (0%)	0/6 (0%)	3/6 (50%)
CHF 10067 3000 mg (Test Treatment)	0/6 (0%)	1/6 (16.7%)	5/6 (83.3%)
Placebo	0/6 (0%)	0/6 (0%)	4/6 (66.7%)

Most frequent serious events

Most frequent serious events
Event	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
InfluenzaInfections and infestations	0/6	0/6	1/6	0/6

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo
Lower Respiratory Tract InfectionInfections and infestations	2/6	0/6	0/6	0/6
NasopharyngitisInfections and infestations	0/6	2/6	0/6	1/6
DizzinessNervous system disorders	2/6	0/6	0/6	0/6
HeadacheNervous system disorders	0/6	0/6	2/6	1/6
HypertensionVascular disorders	1/6	0/6	2/6	0/6
Supraventricular ExtrasystolesCardiac disorders	0/6	0/6	0/6	1/6
Periorbital OedemaEye disorders	1/6	0/6	0/6	0/6
DiarrhoeaGastrointestinal disorders	0/6	0/6	1/6	1/6
NauseaGastrointestinal disorders	0/6	0/6	0/6	1/6
VomitingGastrointestinal disorders	0/6	0/6	1/6	1/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Mean	60.7 ± 7.3	61.8 ± 8.0	58.7 ± 8.2	70.7 ± 4.1	63.0 ± 8.1

Sex: Female, Male
Sex: Female, Male(Participants)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Female	1	2	5	0	8
Male	5	4	1	6	16

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	6	6	6	6	24
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Mean	25.98 ± 2.17	30.23 ± 3.66	30.02 ± 4.18	27.80 ± 1.90	28.51 ± 3.42

Smoking status at screening
Smoking status at screening(Participants)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Tobacco: Ex-smoker	3	3	3	4	13
Tobacco: Non-smoker	3	3	3	2	11
E-cigarettes: Ex-smoker	0	0	0	0	0
E-cigarettes: Non-smoker	6	6	6	6	24

Duration of smoking
Duration of smoking(years)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Mean	40.3 ± 7.8	33.7 ± 16.3	21.7 ± 5.7	24.5 ± 16.3	29.6 ± 13.5

Number of pack-years
Number of pack-years(pack-years)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Mean	18.60 ± 8.79	22.43 ± 18.60	20.00 ± 7.00	18.00 ± 13.98	19.62 ± 11.43

Time since diagnosis
Time since diagnosis(years)	CHF 10067 1000 mg (Test Treatment)	CHF 10067 2000 mg (Test Treatment)	CHF 10067 3000 mg (Test Treatment)	Placebo	Total
Median	1.25 (0.6 to 4.1)	0.79 (0.3 to 4.1)	1.21 (0.0 to 4.4)	1.40 (0.2 to 4.6)	1.00 (0.0 to 4.6)

7 further baseline measures are reported on the registry.

Study locations

9 sites

PHI University Clinic of Pulmonology and Allergology
Skopje, 1000, North Macedonia
Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials
Kyiv, 01135, Ukraine
Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus
Cambridge, CB2 0AY, United Kingdom
University of Dundee, NHS Tayside - Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,
Edinburgh, EH16 4SA, United Kingdom
Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust
Liverpool, L7 8XP, United Kingdom
Medicines Evaluation Unit - The Langley Building
Manchester, M23 9QZ, United Kingdom
University Hospital Southampton - Department of Respiratory Medicine
Southampton, United Kingdom

References and documents

Study documents

Study protocol · Jul 6, 2023
Statistical analysis plan · May 30, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05513950
Lead sponsor: Chiesi Farmaceutici S.p.A.
Responsible party: Sponsor
First posted: Aug 24, 2022
Start date: Jan 25, 2023
Primary completion: Jun 17, 2024
Completion: Jun 17, 2024
Results posted: Aug 14, 2025
Last update: Aug 14, 2025

Study contacts

Lisa Spencer

principal investigator · Liverpool University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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