NCT05513950

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-25
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2022-08-24
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

9 sites across 3 countries: North Macedonia, Ukraine, United Kingdom