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CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Study Purpose
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD)
of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Male or female patients ≥ 40 years of age.
- Documented diagnosis of IPF.
Exclusion Criteria:
- History of clinically significant cardiovascular disease, including myocardial
infarction, unstable ischemic heart disease, congestive heart failure, or angina
during the 6 months before screening.
- Sinoatrial or atrioventricular block, uncontrolled hypertension.
- Active bleeding or current clinically significant coagulopathy
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
CSL Behring
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Study Director
Principal Investigator Affiliation
CSL Behring
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Poland, Spain, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Experimental: CSL312
Administered IV and SC
Placebo Comparator: Placebo
Administered IV and SC
Interventions
Drug: - CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Drug: - Placebo
Same as the CSL312 formulation buffer
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
The University of Alabama at Birmingham, Birmingham, Alabama
