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

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 25, 2023

Primary Completion Date

June 17, 2024

Study Completion Date

June 17, 2024

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
BIOLOGICAL

CHF10067 starting dose -- 1000mg (Cohort A)

Intravenous administration of a starting dose of the monoclonal antibody

BIOLOGICAL

CHF10067 intermediate dose -- 2000mg (Cohort B)

Intravenous administration of an intermediate dose of the monoclonal antibody

BIOLOGICAL

CHF10067 high dose -- 3000mg (Cohort C)

Intravenous administration of a high dose of the monoclonal antibody

DRUG

Placebo

Intravenous administration of a physiological solution as placebo

Trial Locations (9)

1000

PHI University Clinic of Pulmonology and Allergology, Skopje

01135

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

B15 2TH

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

CB2 0AY

Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus, Cambridge

DD1 9SY

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

EH16 4SA

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

L7 8XP

Liverpool Clinical Research Facility - Liverpool University Hospital Foundation Trust, Liverpool

M23 9QZ

Medicines Evaluation Unit - The Langley Building, Manchester

Unknown

University Hospital Southampton - Department of Respiratory Medicine, Southampton

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY