| Trial ID: | L0290 |
| Source ID: | NCT04829123
|
| Associated Drug: |
HEC88473
|
| Title: |
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: HEC88473 injection|Drug: Placebo
|
| Outcome Measures: |
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473|Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473|Cmax|AUC|OGTT|Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
|
| Sponsor/Collaborators: |
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
|
| Gender: |
All
|
| Age: |
18 Years to 60 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
May 29, 2021
|
| Completion Date: |
December 31, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 30, 2021
|
| Locations: |
Scientia Clinical Research, Sydney, Australia
|
| URL: |
https://ClinicalTrials.gov/show/NCT04829123
|