A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.
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 - 80 Years |
Gender | All |
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. |
NCT03538301 |
Phase
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. |
Nitto Denko Corporation |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Nitto Denko Corporation |
Principal Investigator Affiliation | Nitto Denko Corporation |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Germany, Japan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis |
Experimental: ND-L02-s0201 (Dose Level 1)
Experimental: ND-L02-s0201 (Dose Level 2)
Placebo Comparator: Placebo
Drug: - ND-L02-s0201
Intravenous administration every 2 weeks
Drug: - ND-L02-s0201
Intravenous administration every 2 weeks
Other: - Other: Placebo
Saline
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.
Status
Recruiting
Address
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Status
Recruiting
Address
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, 94143
Status
Recruiting
Address
Mayo Clinic Florida
Jacksonville, Florida, 32224
Status
Recruiting
Address
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Status
Recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Recruiting
Address
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
Status
Recruiting
Address
Norton Clinical Research Group
Louisville, Kentucky, 40218
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Status
Recruiting
Address
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, 03756
Status
Recruiting
Address
Duke University Hospital
Durham, North Carolina, 27708
Status
Recruiting
Address
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390
Status
Recruiting
Address
UT Health San Antonio: First Outpatient Research Unit
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Utah Health
Salt Lake City, Utah, 84108
Status
Recruiting
Address
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wuerttemberg, 69126
Status
Recruiting
Address
Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376
Status
Recruiting
Address
Medizinische Hochschule Hannover (MHH)
Hannover, Lower Saxony, 30625
Status
Recruiting
Address
Ruhrlandklinik, Universitatmedzin Essen
Essen, North Rhine-Westphalia, NRW 45239
Status
Recruiting
Address
National Hospital Organization Himeji Medical Center
Himeji-Shi, Hyogo, 670-8520
Status
Recruiting
Address
National Hospital Organization Ibarakihigashi National Hospital
Naka-gun, Ibaraki, 319-1113
Status
Recruiting
Address
Kanagawa Cardiovascular and Respiratory Center
Yokohama-shi, Kanagawa, 236-0051
Status
Recruiting
Address
National Hospital Oganization Kinki-chuo Chest Medical Center
Osaka, Sakai-shi, 5918555
Status
Recruiting
Address
Tosei General Hospital
Aichi, Seto-shi, 489-8642
Status
Recruiting
Address
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
Status
Recruiting
Address
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Status
Recruiting
Address
The Medicines Evaluation Unit (MEU) Ltd.
Manchester, , M23 9QZ
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