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
← catalyst calendarSponsored by Aligos Therapeutics (industry) · ALGS — their whole pipeline →. With National Institute of Allergy and Infectious Diseases (NIAID).
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
12actual
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-20 | actual | When the study began enrolling |
| Primary completion | 2025-07-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-13 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-21 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-09 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- COVID 19
Intervention
- Drug: ALG-097558
Primary outcomes
what the primary-completion date above is the date OFArea Under the Concentration Time Curve [AUC]
measured Pre-dose (-0.75 hours) up to Day 8
Maximum Plasma Concentration [Cmax]
measured Pre-dose (-0.75 hours) up to Day 8
Minimum Plasma Concentration [Cmin]
measured Pre-dose (-0.75 hours) up to Day 8
C0 [Predose]
measured Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]
measured Pre-dose (-0.75 hours) up to Day 8
Time to Maximum Plasma Concentration [Tmax]
measured Pre-dose (-0.75 hours) up to Day 8
Apparent Clearance (CL/F)
measured Pre-dose (-0.75 hours) up to Day 8
Apparent Volume of Distribution (V/F)
measured Pre-dose (-0.75 hours) up to Day 8
Total Amount of Drug Excreted in Urine (Ae)
measured Pre-dose (-0.75 hours) up to Day 8
Renal Clearance (CLr)
measured Pre-dose (-0.75 hours) up to Day 8
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-11-06 · 935 KB · Prot_SAP_000.pdf
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