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NCT03261739 · ClinicalTrials.gov registry record · Phase 1
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 1 study of NAFLD, sponsored by Bird Rock Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 6
- Study locations
NCT03261739: Completed Phase 1 study of NAFLD, sponsored by Bird Rock Bio.
NCT03261739 is a Phase 1 study of NAFLD that has completed, run by Bird Rock Bio. The registered enrollment target is 84 participants, below the 162-participant average among 26 other NAFLD trials with a reported enrollment target (48% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03261739, a Phase 1 study of NAFLD, has completed, sponsored by Bird Rock Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 6
- Study locations
Study Summary
BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
Primary Outcome
Subjects will be assessed for adverse events attributable to RYI-018
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RYI-018
Study Locations (6)
Florida
- BRB Site - Miami
- BRB Site - Orlando
California
- BRB Site - Chula Vista
Texas
- BRB Site - San Antonio
Western Australia
- BRB Site - Nedlands
Ontario
- BRB Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2018-08-24 |
| Phase | Phase 1 |
What the finished NCT03261739 record still lists
NCT03261739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 162-participant average among 26 other NAFLD trials with a reported enrollment target (48% lower).
The record links to 1 condition, with NAFLD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03261739 lists 6 locations in 5 states (Florida, California, Texas).
Frequently Asked Questions
What is clinical trial NCT03261739 about?
NCT03261739 is a clinical study titled "Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)". BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
What is the current status of trial NCT03261739?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2017-08-28. Estimated completion is 2018-08-24.
What conditions does trial NCT03261739 study?
This clinical trial studies the following conditions: NAFLD.
What interventions are being tested in trial NCT03261739?
The interventions under investigation include: Placebo (BIOLOGICAL), RYI-018 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03261739?
This trial is sponsored by Bird Rock Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03261739 being conducted?
This trial has 6 study locations across California, Florida, Texas, Western Australia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NAFLD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03261739's enrollment target sits among peer trials
84 12th of 26 higher than 15 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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