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

NCT05513950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-14

Study results available
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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).

Conditions

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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Lisa Spencer · Liverpool University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2024-06-17
Completion
2024-06-17

Countries

  • North Macedonia
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513950 on ClinicalTrials.gov