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NCT06568861
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
Phase 1 trial testing ALG-097558 in COVID-19 in 16 participants. Completed in 28 July 2025.
28 July 2025
Quick facts
| Lead sponsor | Aligos Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 14 January 2025 |
| Primary completion | 28 July 2025 |
| Estimated completion | 28 July 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- ALG-097558 — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Aligos Therapeutics — full company profile →
Who can join
Adults 18 to 75, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic 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 hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06568861
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ALG-097558
Trials testing the same drug.
- NCT06945276 — Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers · Phase 1 · completed
- NCT06698549 — A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in · Phase 1 · completed
- NCT05840952 — A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, · Phase 1 · completed
- NCT04746183 — AGILE (Early Phase Platform Trial for COVID-19) · Phase 1, PHASE2 · recruiting
Other recruiting trials for COVID-19
Currently open trials in the same condition.
- NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Aligos Therapeutics trials
Trials by the same sponsor.
- NCT07342881 — Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Part · Phase 1 · recruiting
- NCT07342868 — Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Sub · Phase 1 · recruiting
- NCT06959888 — A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations · Phase 1 · completed
- NCT06698549 — A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in · Phase 1 · completed
- NCT06672900 — A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06568861 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aligos Therapeutics
- Last refreshed: 20 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06568861.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing