Effects of CSL324 in the Lung After Segmental Challenge
NCT05653713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-11-29
Summary
This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
CSL324
Single intravenous (IV) dose of CSL324
- DRUG
-
IV dose of 0.9% saline
Sponsors & Collaborators
-
CSL Behring
lead INDUSTRY
Principal Investigators
-
Study Director · CSL Behring
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-20
- Primary Completion
- 2023-07-21
- Completion
- 2023-07-21
Countries
- Germany
Study Locations
More Related Trials
-
Effects of Bronchial Segmental Endotoxin Instillation in Humans
NCT02392442 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)
NCT04643587 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
NCT01225965 ·Status: COMPLETED ·Phase: NA
-
Phase 1a Study in Healthy Smokers to Investigate the Effect With MMI-0100 on Airway Inflammation in Induced Sputum After Challenge With Inhaled Lipopolysaccharide
NCT02515396 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure
NCT04574869 ·Status: WITHDRAWN ·Phase: PHASE1
-
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
NCT01597635 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Biomarkers of Airway Inflammation (0000-128)
NCT00869596 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease
NCT01322594 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults
NCT06677918 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects
NCT02058407 ·Status: TERMINATED ·Phase: PHASE1
-
A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
NCT01364519 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
NCT02679729 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT03591926 ·Status: WITHDRAWN ·Phase: PHASE2
-
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
NCT07048262 ·Status: RECRUITING ·Phase: PHASE2
-
Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers
NCT06217952 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
NCT01690949 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
NCT04720443 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
NCT07053423 ·Status: RECRUITING ·Phase: PHASE4
-
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
NCT05892614 ·Status: RECRUITING ·Phase: PHASE2
-
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
NCT05010577 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of the Dry Powder Formulation of GSK2269557 in Healthy Subjects
NCT01762878 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
NCT01818544 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
NCT04093024 ·Status: COMPLETED ·Phase: PHASE3
-
Scleroderma Lung Disease
NCT00004563 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers
NCT03691584 ·Status: COMPLETED ·Phase: PHASE1