ALG-097558 for Kidney Failure

Recruiting at 2 trial locations

Overseen By Jen Rito

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aligos Therapeutics

Disqualifiers: Cardiac disease, Drug abuse, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have impaired kidney function, you must have been on stable medications for at least 28 days before the trial.

Are You a Good Fit for This Trial?

This trial is for adults with severe kidney failure and healthy individuals with normal kidney function, ideally matched by age, weight, and if possible, gender. Specific eligibility criteria are not provided but typically include factors like stable health status and no conflicting medications or conditions.

Inclusion Criteria

Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)

I am not able to have children or will use effective birth control.

Exclusion Criteria

Positive pregnancy test; females must not be pregnant at enrollment

My hemoglobin is below 9 g/dL and I have kidney issues.

I do not have active Hepatitis A, B, C, E, HIV, or COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of 300 mg ALG-097558 twice daily for 6 days

1 week

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALG-097558

Trial Overview The study is testing ALG-097558's behavior in the body (pharmacokinetics) when given orally twice a day to people with severe renal impairment compared to those without. It aims to understand how kidney function affects the drug's processing.

How Is the Trial Designed?

Group I: Subjects with Severe Renal Impairment Experimental Treatment 1 Intervention

Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group II: Subjects with Normal Renal Function Experimental Treatment 1 Intervention

Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group III: Subjects with Moderate Renal Impairment (Optional) Experimental Treatment 1 Intervention

Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group IV: Subjects with Mild Renal Impairment (Optional) Experimental Treatment 1 Intervention

Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

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

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+