A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic 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
16actual
Sites
2
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 | 2025-01-13 | actual | When the study began enrolling |
| Primary completion | 2025-07-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-28 | actual | The whole study's end, after follow-up |
| First posted | 2024-08-23 | actual | When this record first appeared on the registry |
| Results posted | 2026-08-05 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-05 | 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 AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Time to Maximum Plasma Concentration [Tmax]
measured Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Maximum Plasma Concentration [Cmax]
measured Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Minimum Plasma Concentration [Cmin]
measured Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only
C0 [Predose]
measured Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]
measured Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 only
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-09-30 · 870 KB · Prot_SAP_000.pdf
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