This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to ATYR1923 (N=8) or placebo (N=4).
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 | 18 Years - 70 Years |
Gender | All |
Key
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. |
NCT03824392 |
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 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
aTyr Pharma, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Gennyne Walker |
Principal Investigator Affiliation | aTyr Pharma, Inc. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
IndustryOther |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Sarcoidosis |
Experimental: Cohort 1
ATYR1923 1.0 mg/kg or placebo
Experimental: Cohort 2
ATYR1923 3.0 mg/kg or placebo
Experimental: Cohort 3
ATYR1923 5.0 mg/kg or placebo
Biological: - ATYR1923 1.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 1.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
Biological: - ATYR1923 3.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 3.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
Biological: - ATYR1923 5.0 mg/kg or placebo
ATYR1923 participants to receive ATYR1923 5.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
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
University of Alabama
Birmingham, Alabama, 35294-0006
Status
Recruiting
Address
aTyr Investigative Site
Northridge, California, 91324
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Recruiting
Address
aTyr Investigative Site
Miami, Florida, 33125
Status
Recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Recruiting
Address
Northwestern University
Chicago, Illinois, 60611
Status
Recruiting
Address
aTyr Investigative Site
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Iowa
Iowa City, Iowa, 52242
Status
Recruiting
Address
University of Louisville
Louisville, Kentucky, 40202
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Recruiting
Address
East Carolina University
Greenville, North Carolina, 27858
Status
Recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
aTyr Investigative Site
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 92425
Status
Recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390
Status
Recruiting
Address
Inova Fairfax Medical Center
Falls Church, Virginia, 22042
The Pulmonary Fibrosis Foundation rates among top charities in the U.S. The PFF has a three-star rating from Charity Navigator and is a Better Business Bureau accredited charity.