| Trial ID: | L0305 |
| Source ID: | NCT04481594
|
| Associated Drug: |
HPN-01
|
| Title: |
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: HPN-01|Drug: Placebo
|
| Outcome Measures: |
Single-dose PK Parameter|Multiple-dose PK Parameters|Incidence of Adverse Events|Proportion of Participants with 12-lead ECG Abnormalities|Proportion of Participants with Clinical Laboratory Abnormalities|Measurement of PD Biomarker Level of Fibroblast Growth Factor 19 (FGF19) Following Oral Single and Multiple Ascending Dose Administration|Measurement of PD Biomarker Level of C4 Following Oral Single and Multiple Ascending Dose Administration
|
| Sponsor/Collaborators: |
Hepanova Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
72
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
September 8, 2020
|
| Completion Date: |
July 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 10, 2021
|
| Locations: |
Frontage Clinical Services, Inc, Secaucus, New Jersey, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04481594
|
