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Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)

NCT04643587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-12-15

No results posted yet for this study

Summary

This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.

Conditions

  • Noncystic Fibrosis Bronchiectasis (NCFB)

Interventions

BIOLOGICAL

CSL787

Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer

DRUG

Placebo

Normal saline (0.9% NaCl)

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2023-03-12
Completion
2023-03-12

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04643587 on ClinicalTrials.gov