| Trial ID: | L0112 |
| Source ID: | NCT03261739
|
| Associated Drug: |
RYI-018
|
| Title: |
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD
|
| Interventions: |
Biological: RYI-018|Biological: Placebo
|
| Outcome Measures: |
Clinical evaluation of adverse events|Time to peak serum concentration|Peak serum concentration|Area under the serum concentration versus time curve (AUC)|Apparent volume of distribution|Immunogenicity as determined by the concentration of serum anti-RYI-018 antibodies.
|
| Sponsor/Collaborators: |
Bird Rock Bio, Inc.|ProSciento, Inc.|Perspectum
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
84
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
August 28, 2017
|
| Completion Date: |
August 24, 2018
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 14, 2019
|
| Locations: |
BRB Site, Chula Vista, California, United States|BRB Site, Miami, Florida, United States|BRB Site, Orlando, Florida, United States|BRB Site, San Antonio, Texas, United States|BRB Site, Nedlands, Western Australia, Australia|BRB Site, Toronto, Ontario, Canada
|
| URL: |
https://ClinicalTrials.gov/show/NCT03261739
|
