| Trial ID: | L0316 |
| Source ID: | NCT05012423
|
| Associated Drug: |
ECC0509
|
| Title: |
FTIH Study of ECC0509 in Healthy Volunteers
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis|Osteoarthritis
|
| Interventions: |
Drug: Placebo|Drug: ECC0509
|
| Outcome Measures: |
Number of subjects with adverse events and serious adverse events|Number of subjects with abnormal values for blood pressure|Number of subjects with abnormal values for pulse rate|Number of subjects with abnormal values for respiratory rate|Number of subjects with abnormal values for tympanic temperature|Number of subjects with abnormal values for electrocardiogram parameters|Number of subjects with abnormal findings for clinical chemistry parameters|Number of subjects with abnormal findings for hematology parameters|Number of subjects with abnormal findings for coagulation parameters|Number of subjects with abnormal findings for urinalysis parameters|Pharmacokinetic assessment 1|Pharmacokinetic assessment 2|Pharmacokinetic assessment 3|Pharmacokinetic assessment 4|Pharmacokinetic assessment 5|Pharmacokinetic assessment 6|Pharmacodynamic assessment
|
| Sponsor/Collaborators: |
Eccanga Pty Ltd|Syneos Health|Eccogene (Shanghai) Co. Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
86
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
July 7, 2021
|
| Completion Date: |
February 20, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 19, 2021
|
| Locations: |
CMAX Clinical Research, Adelaide, South Australia, Australia
|
| URL: |
https://ClinicalTrials.gov/show/NCT05012423
|
