A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
Completed · Phase 1
Conditions studied: COVID 19
In brief
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
Key facts
- Study ID
- NCT06698549
- Run by
- Aligos Therapeutics
- People needed
- 12
- Starts
- 2025-02-20
- Expected to finish
- 2025-08-13
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- University of Miami — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Genesis Clinical Trials — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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