| Trial ID: | L0295 |
| Source ID: | NCT05143905
|
| Associated Drug: |
AZD7503
|
| Title: |
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: AZD7503|Drug: Placebo
|
| Outcome Measures: |
Number of participants with Adverse Events (AEs)|Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503|Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD7503|Maximum observed plasma (peak) drug concentration (Cmax) of AZD7503|Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD7503|Time of last observed (quantifiable) concentration (tlast) of AZD7503|Partial area under the plasma concentration-time curve from time 0 to time 48 hours post dose [AUC(0-48)] of AZD7503|Half-life associated with terminal slope (??z) of a semi logarithmic concentration time curve (t????z) of AZD7503|Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD7503|Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD7503|Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD7503|Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD7503|Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD7503|Renal clearance of drug from plasma (CLR) of AZD7503|Number of participants with positive anti-drug antibodies (ADA) of AZD7503
|
| Sponsor/Collaborators: |
AstraZeneca
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
72
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
|
| Start Date: |
December 6, 2021
|
| Completion Date: |
November 21, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 15, 2022
|
| Locations: |
Research Site, Glendale, California, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT05143905
|
