Multicenter ascending study of nebulized CSL787 in healthy&NCFB subj
Research type
Research Study
Full title
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects with Non-Cystic Fibrosis Bronchiectasis (NCFB)
IRAS ID
288229
Contact name
Damien Downey
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2020-002684-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 5 days
Research summary
CSL787 is a 10% solution of human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer. CSL787 contains approximately 250 mmol/L of L-proline as a stabilizer and trace amounts of sodium. 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 in healthy subjects and subjects with mild NCFB.
Approximately 64 subjects will be randomized into this study. CSL787 will
be administered at doses up to 10 mg/kg.This is a research study that will investigate the safety (how well the human body tolerate the drug), pharmacokinetics (the amount of drug and its breakdown products in body), pharmacodynamics (how body responds to the study drug) and efficacy (if the study drug works) of a new drug called CSL787.
CSL Behring is developing CSL787 for the potential treatment of lung infections in patients with lung disorders such as Non-Cystic Fibrosis Bronchiectasis (NCFB). In NCFB, parts of the lung tubes (airways) become damaged and wider than normal. These wider areas are less effective at clearing mucus (sputum) from the lungs and so mucus gathers and may become infected with bacteria. Infections can cause the lungs to become inflamed, which can damage parts of the lung. CSL787 is an antibody solution that contains natural antibodies known as immunoglobulin G (IgG). It is made from plasma (the liquid part of blood without blood cells) collected from healthy adult blood donors. Antibodies are the active component of CSL787. Antibodies are a part of the immune system that target and help destroy many potentially harmful organisms (pathogens) such as bacteria and viruses. In this study the subject will breathe the study drug (or placebo) into the lungs using a nebulizer (a device that turns the study drug (or placebo) into a mist).
In this study we will see how CSL787 compares with placebo. A placebo looks like the study drug but does not contain any active medicine. Researchers use a placebo to see if a study drug works better or is safer than not taking anything at all.
The study will be performed in two parts, Part A and Part B. In Part A approximately 40 healthy adults will take part in the study. In Part B approximately 24 patients with NCFB will take part in the study. It is anticipated that the study will be performed at up to 2 sites in the UK.REC name
HSC REC B
REC reference
20/NI/0120
Date of REC Opinion
23 Oct 2020
REC opinion
Further Information Favourable Opinion