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NCT06698549
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
Phase 1 trial testing ALG-097558 in COVID 19 in 12 participants. Completed in 21 July 2025.
21 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 | 12 |
| Start date | 1 February 2025 |
| Primary completion | 21 July 2025 |
| Estimated completion | 21 July 2025 |
| Sites | 3 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 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.
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 NCT06698549
- 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
- NCT06568861 — A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and · 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.
- NCT06871293 — Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19 · NA · recruiting
- NCT06599658 — COVID-19 Booster and IIV Schedule in Immunocompromised Hosts · Phase 2 · recruiting
- NCT04359836 — A Study to Explore the Role of Gut Flora in COVID-19 Infection · recruiting
- NCT04522076 — Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acq · active not recruiting
- NCT06702540 — Bio-reconfigurable Electronic Platform for Multiplex Detection of Viral Respiratory Pathogens · 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
- NCT06568861 — A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and · 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 NCT06698549 (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/NCT06698549.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing