Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

A Phase 1 Non-Randomized, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B Infection
• Intervention / Treatment: Drug: Pevifoscorvir Sodium (ALG-000184)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Aligos Therapeutics Therapeutics; Phone Number: (800) 466-6059; Email: info@aligos.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
      • Contact: Derek Bell; Email: dbell@ocrc.net
    • Tampa, Florida, United States, 33603
      • Recruiting
      • Genesis Clinical Trials
      • Contact: Derik Navarro; Email: dnavarro@genesistrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for All Subjects:

1. Male and Female between 18 and 75 years old
2. Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy

Inclusion Criteria for Subjects with Normal Renal Function:

1. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, sex
3. Normal renal function (estimated Glomerular Filtration Rate [eGFR] ≥90 mL/min) with no known or suspected renal impairment

Inclusion Criteria for Subjects with Impaired Renal Function:

1. Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration
2. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
3. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening
4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

Exclusion Criteria for All Subjects:

1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation
2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or recent history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >2x upper limit of normal (ULN)
9. Subjects with bilirubin (total, direct) >1.5x ULN (unless Gilbert's is suspected)
10. Positive pregnancy test; females must not be pregnant at enrollment

Exclusion Criteria for Subjects with Normal Renal Function:

1. Hemoglobin <10 g/dL

Exclusion Criteria for Subjects with Impaired Renal Function:

1. Participants requiring hemodialysis and/or peritoneal dialysis
2. Hemoglobin <9 g/dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with renal Impairment; Subjects with renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.	Drug: Pevifoscorvir Sodium (ALG-000184); Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
Experimental: Subjects without renal impairment; Subjects without renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.	Drug: Pevifoscorvir Sodium (ALG-000184); Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration time curve [AUC]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 days
Maximum plasma concentration [Cmax]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Minimum plasma concentration [Cmin]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
C0 [predose]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 days
Half-life [t1/2]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Time to maximum plasma concentration [Tmax]	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Apparent Clearance (CL/F)	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Apparent Volume of Distribution (V/F)	Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Total Amount of Drug Excreted in Urine (Ae)	Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days
Renal Clearance (CLr)	Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302	Up to 4 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1	Up to 15 days

Collaborators and Investigators

• Sponsor: Aligos Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Hepatitis B Infection
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: ALG-000184-208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No