| Trial ID: | L0268 |
| Source ID: | NCT04202354
|
| Associated Drug: |
ARO-HSD
|
| Title: |
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: ARO-HSD Injection|Drug: sterile normal saline (0.9% NaCl)
|
| Outcome Measures: |
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment|PK of ARO-HSD: Maximum observed Plasma Concentration (Cmax)|PK of ARO-HSD: Time to Maximum Plasma Concentration (Tmax)|PK of ARO-HSD: Terminal Elimination Half-Life (t1/2)|PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)|PK of ARO-HSD: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
|
| Sponsor/Collaborators: |
Arrowhead Pharmaceuticals
|
| Gender: |
All
|
| Age: |
19 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
50
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
March 3, 2020
|
| Completion Date: |
November 23, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 6, 2021
|
| Locations: |
Auckland Clinical Studies, Grafton, Auckland, New Zealand
|
| URL: |
https://ClinicalTrials.gov/show/NCT04202354
|
