Who is sponsoring NCT05513950?

NCT05513950 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT05513950?

Interventions in NCT05513950: CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C), Placebo.

What condition does NCT05513950 study?

NCT05513950 studies Idiopathic Pulmonary Fibrosis.

Is NCT05513950 still recruiting?

NCT05513950 is currently completed. Last updated 14 August 2025.

Are results published for NCT05513950?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-14 · How we verify

NCT05513950

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 14 August 2025

What this trial tests

Phase 1 trial testing CHF10067 starting dose -- 1000mg (Cohort A) in Idiopathic Pulmonary Fibrosis in 52 participants. Completed in 17 June 2024.

Timeline

25 January 2023

Primary endpoint
17 June 2024

17 June 2024

Quick facts

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	52
Start date	25 January 2023
Primary completion	17 June 2024
Estimated completion	17 June 2024
Sites	9 locations across United Kingdom, North Macedonia, Ukraine

Drugs / interventions tested

CHF10067 starting dose -- 1000mg (Cohort A) — full drug profile →
CHF10067 intermediate dose -- 2000mg (Cohort B) — full drug profile →
CHF10067 high dose -- 3000mg (Cohort C) — full drug profile →
Placebo

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Chiesi Farmaceutici S.p.A. — full company profile →

Who can join

40 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

1_Subjects With Adverse Event (AE); Non-Serious AEs and Serious AEs Primary · 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.

Serious TEAE

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	0
CHF 10067 2000 mg (Test Treatment)	0
CHF 10067 3000 mg (Test Treatment)	1
Placebo	0

Non-serious TEAE

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	4
CHF 10067 2000 mg (Test Treatment)	3
CHF 10067 3000 mg (Test Treatment)	5
Placebo	4

AE leading to study treatment discontinuation

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	0
CHF 10067 2000 mg (Test Treatment)	0
CHF 10067 3000 mg (Test Treatment)	0
Placebo	0

AE leading to death

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	0
CHF 10067 2000 mg (Test Treatment)	0
CHF 10067 3000 mg (Test Treatment)	0
Placebo	0

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

Evaluate the area under the concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) of CHF10067 after a single dose.

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3424	± 647
CHF 10067 2000 mg (Test Treatment)	7902	± 1001
CHF 10067 3000 mg (Test Treatment)	15592	± 3027

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

Evaluate the area under the concentration-time curve (AUC) from zero to infinity (AUC0-∞) of CHF10067 after a single dose.

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3450	± 660
CHF 10067 2000 mg (Test Treatment)	8141	± 1112
CHF 10067 3000 mg (Test Treatment)	16328	± 3245

4_Pharmacokinetics -- Maximum Plasma Concentration (Cmax) Secondary · 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.

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

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	307	± 43.9
CHF 10067 2000 mg (Test Treatment)	668	± 126
CHF 10067 3000 mg (Test Treatment)	1067	± 173

5_Pharmacokinetics -- Time to Maximum Observed Concentration (Tmax) Secondary · 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.

Evaluate the time to maximum observed concentration (tmax).

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	1.69	1.67 – 3.67
CHF 10067 2000 mg (Test Treatment)	3.78	3.58 – 11.67
CHF 10067 3000 mg (Test Treatment)	5.39	5.35 – 7.43

6_Pharmacokinetics -- Serum Concentration at the End of Infusion (Cinf) Secondary · Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).

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

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	304	± 44.6
CHF 10067 2000 mg (Test Treatment)	658	± 138
CHF 10067 3000 mg (Test Treatment)	1065	± 174

7_Pharmacokinetics -- Time at the End of Infusion (Tinf) Secondary · Pre-dose (within 75 min from start of infusion, baseline), at the end of infusion (up to 6 hours from the start of infusion).

Evaluate the time of serum concentration at the end of infusion (Tinf). Time at the end of the infusion.

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	1.68	1.67 – 1.72
CHF 10067 2000 mg (Test Treatment)	3.69	3.58 – 3.85
CHF 10067 3000 mg (Test Treatment)	5.38	5.35 – 5.50

8_Pharmacokinetics -- Clearance (CL) Secondary · 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.

Evaluate clearance (CL) of CHF10067.

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	0.295	± 0.0489
CHF 10067 2000 mg (Test Treatment)	0.250	± 0.0357
CHF 10067 3000 mg (Test Treatment)	0.190	± 0.0363

9_Pharmacokinetics -- Volume of Distribution (Vz) Secondary · 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.

Evaluate volume of distribution (Vz) CHF10067.

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	4.93	± 0.969
CHF 10067 2000 mg (Test Treatment)	5.99	± 0.716
CHF 10067 3000 mg (Test Treatment)	5.21	± 1.03

10_Pharmacokinetics -- Terminal Half-life (t1/2) Secondary · From pre-dose (baseline) up to day 84.

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

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	11.7	± 2.20
CHF 10067 2000 mg (Test Treatment)	16.8	± 2.32
CHF 10067 3000 mg (Test Treatment)	19.1	± 1.93

11_Spirometry -- Forced Expiratory Volume in the First Second (FEV1) -- Percent Predicted -- Change From Baseline Secondary · Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.

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.

Day 7

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3.93	± 3.35
CHF 10067 2000 mg (Test Treatment)	0.50	± 2.74
CHF 10067 3000 mg (Test Treatment)	-0.20	± 1.34
Placebo	-0.43	± 2.60

Day 28

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3.76	± 3.66
CHF 10067 2000 mg (Test Treatment)	-0.55	± 3.06
CHF 10067 3000 mg (Test Treatment)	-2.93	± 2.81
Placebo	-0.55	± 3.37

Day 56

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3.18	± 3.58
CHF 10067 2000 mg (Test Treatment)	-0.68	± 3.54
CHF 10067 3000 mg (Test Treatment)	-0.75	± 5.68
Placebo	-1.35	± 2.93

Day 84

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	0.13	± 5.57
CHF 10067 2000 mg (Test Treatment)	0.36	± 4.30
CHF 10067 3000 mg (Test Treatment)	-2.70	± 2.93
Placebo	-1.40	± 3.62

12_Spirometry -- Forced Vital Capacity (FVC) -- Percent Predicted -- Change From Baseline Secondary · Text adjusted Pre-dose (baseline), and on 7, 28, 56, and 84 day post-dose.

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.

Day 7

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	3.12	± 2.24
CHF 10067 2000 mg (Test Treatment)	-0.90	± 3.31
CHF 10067 3000 mg (Test Treatment)	-0.50	± 2.89
Placebo	-0.92	± 3.80

Day 28

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	2.70	± 3.74
CHF 10067 2000 mg (Test Treatment)	-0.50	± 2.58
CHF 10067 3000 mg (Test Treatment)	-3.23	± 2.76
Placebo	-0.13	± 4.10

Day 56

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	2.50	± 1.87
CHF 10067 2000 mg (Test Treatment)	-1.17	± 3.12
CHF 10067 3000 mg (Test Treatment)	-1.42	± 6.55
Placebo	-0.90	± 2.84

Day 84

Group	Value	95% CI
CHF 10067 1000 mg (Test Treatment)	-0.72	± 4.02
CHF 10067 2000 mg (Test Treatment)	-0.36	± 3.56
CHF 10067 3000 mg (Test Treatment)	-1.98	± 3.79
Placebo	-1.97	± 3.22

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AE) were reported from the time of patient informed consent signature until subject's study participation ended (day 84 or early withdrawal).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CHF 10067 1000 mg (Test Treatment)

Serious: 0/6 (0%)

Deaths: 0/6

CHF 10067 2000 mg (Test Treatment)

Serious: 0/6 (0%)

Deaths: 0/6

CHF 10067 3000 mg (Test Treatment)

Serious: 1/6 (17%)

Deaths: 0/6

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Serious adverse events (1 terms)

Reaction	System	CHF 10067 1000 mg (Test Tr…	CHF 10067 2000 mg (Test Tr…	CHF 10067 3000 mg (Test Tr…	Placebo
Influenza	Infections and infestations	—	—	—	—

Other adverse events (31 terms — click to expand)

Reaction	System	CHF 10067 1000 mg (Test Tr…	CHF 10067 2000 mg (Test Tr…	CHF 10067 3000 mg (Test Tr…	Placebo
Lower Respiratory Tract Infection	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Supraventricular Extrasystoles	Cardiac disorders	—	—	—	—
Periorbital Oedema	Eye disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Medical Device Site Rash	General disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Tinea Pedis	Infections and infestations	—	—	—	—
Skin Abrasion	Injury, poisoning and procedural complications	—	—	—	—
Blood Creatinine Increased	Investigations	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Myositis	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Sputum Discoloured	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dry Skin	Skin and subcutaneous tissue disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—
Flushing	Vascular disorders	—	—	—	—

Most-reported serious reactions: Influenza.

Data from ClinicalTrials.gov NCT05513950 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Idiopathic Pulmonary Fibrosis, Today and Tomorrow: Certainties and New Therapeutic Horizons.
Giulianelli G, Cocconcelli E, Fiorentù G, Bernardinello N, et al · · 2025 · cited 3× · PMID 40323570 · DOI 10.1007/s41030-025-00296-0
Most Promising Emerging Therapies for Pulmonary Fibrosis: Targeting Novel Pathways.
Carriera L, Lipsi R, Dodaj M, Inchingolo R, et al · · 2026 · cited 2× · PMID 41595688 · DOI 10.3390/biomedicines14010154
SPECT as a translational non-invasive method to assess occupancy of the tissue transglutaminase-2 by zampilimab in the mouse lung.
Bellaye PS, Ferrini E, Claron M, Dias A, et al · · 2026 · PMID 41680767 · DOI 10.1186/s12931-026-03566-w

Verify or expand the search:

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting

Other Chiesi Farmaceutici S.p.A. trials

Trials by the same sponsor.

NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05513950 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A.
Last refreshed: 14 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05513950.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05513950

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Other Chiesi Farmaceutici S.p.A. trials

Verify against primary sources