Pevifoscorvir Sodium for Chronic Hepatitis B

Not yet recruiting at 1 trial location
AT
Overseen ByAligos Therapeutics Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Aligos Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with varying degrees of renal impairment or normal kidney function, matched by age, weight, and sex. Participants must be in good health aside from their kidney issues and have stable medications for at least 28 days prior. Women of childbearing potential must use effective contraception.

Inclusion Criteria

I am between 18 and 75 years old.
My BMI is between 17.5 and 40, and I weigh more than 110 lbs.
I am not able to have children or will use effective birth control.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of 100 mg pevifoscorvir sodium

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days
Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

  • Pevifoscorvir Sodium (ALG-000184)

Trial Overview

The study tests Pevifoscorvir Sodium (ALG-000184) in participants with severe to no renal impairment. It's a Phase 1 non-randomized, open-label trial where subjects receive a single dose to assess how the drug behaves in the body and its safety profile.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Subjects without renal impairmentExperimental Treatment1 Intervention
Group II: Subjects with renal ImpairmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials
11
Recruited
960+
Founded
2018
Headquarters
South San Francisco, United States
Known For
Liver & Viral Therapies
Top Products
ALG-000184, ALG-055009, ALG-097558