| Trial ID: | L0410 |
| Source ID: | NCT04561245
|
| Associated Drug: |
ALT-801
|
| Title: |
A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: ALT-801;Other: Placebo
|
| Outcome Measures: |
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs);Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801;Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801;Change in body weight;Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)nan
|
| Sponsor/Collaborators: |
Altimmune, Inc.
|
| Gender: |
All
|
| Age: |
18 Years60 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
| Start Date: |
16/09/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 November 2021
|
| Locations: |
Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT04561245
|
