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A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

Study Purpose

This phase 2 clinical study will be a 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Forced vital capacity (FVC) ≥ 45% of predicted.
  • - Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value - Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

Exclusion Criteria:

  • - Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
  • - Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
  • - Anticipated to receive a lung transplant during the subject's participation in the study.
  • - Active smoker or smoking cessation within 12 weeks before screening.
  • - Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
  • - Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
  • - Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening - Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
  • - Pregnant or breastfeeding.
  • - Medical history of infection with HIV, hepatitis B, or hepatitis C.
  • - History of alcohol abuse and/or dependence within the last 2 years.
  • - History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.
Other protocol defined inclusion/exclusion criteria could apply.

Trial Details

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.

Trial ID:
NCT03538301

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
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Nitto Denko Corporation

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Nitto Denko Corporation
Principal Investigator Affiliation Nitto Denko Corporation

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis

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.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Susan Jackman

Susan.Jackman@cshs.org

310-423-4765

David Geffen School of Medicine at UCLA, Los Angeles, California

Status

Recruiting

Address

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Site Contact

Paul Lopez

PLopez@mednet.ucla.edu

310-795-8595

San Francisco, California

Status

Recruiting

Address

University of California, San Francisco, Medical Center at Parnassus

San Francisco, California, 94143

Site Contact

Reed Norris

Reed.Norris@ucsf.edu

415-476-7054

Mayo Clinic Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Florida

Jacksonville, Florida, 32224

Site Contact

Judy Olmos

Olmos.Judy@mayo.edu

904-953-7898

Central Florida Pulmonary Group, PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803

Site Contact

Sharon Foust

sfoust@cfpulmonary.com

407-841-1100 #135

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

Samantha Smith

samantha.smith@emory.edu

404-727-2011

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Mamary Kone

mkone@mgh.harvard.edu

617-726-1082

Brigham & Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham & Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Sam Wong

ywong6@bwh.harvard.edu

617-525-7654

University of Minnesota Medical School, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota Medical School

Minneapolis, Minnesota, 55455

Site Contact

Tommy Goodwin

goodw020@umn.edu

612-625-7719

Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center (DHMC)

Lebanon, New Hampshire, 03756

Site Contact

Kathy Dickie

kathy.a.dickie@hitchcock.edu

603-650-4711

Duke University Hospital, Durham, North Carolina

Status

Recruiting

Address

Duke University Hospital

Durham, North Carolina, 27708

Site Contact

Shannon Tilley

shannon.tilley@duke.edu

919-668-8854

Penn State Hershey Medical Center, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Michelle Myers

meyersma@upmc.edu

412-692-2149

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Mary- Frances Wolf

wolfmar@musc.edu

843-792-8092

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Rhoda Annoh Gordon

Rhoda.AnnohGordon@utsouthwestern.edu

214-645-7108

University of Utah Health, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health

Salt Lake City, Utah, 84108

Site Contact

Joseph Martinez

Joseph.Martinez@utah.edu

412-692-2149

International Sites

The Medicines Evaluation Unit (MEU) Ltd., Manchester, United Kingdom

Status

Recruiting

Address

The Medicines Evaluation Unit (MEU) Ltd.

Manchester, , M23 9QZ

Site Contact

Simon Pearson

SPearson@meu.org.uk

44 0161 946 4059

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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