Evaluating the effects of ALG-097558 in patients with renal impairment and healthy individuals

A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Renal Impairment and in Healthy Subjects with Normal Renal Function

This study is testing how the drug ALG-097558 works in people with severe kidney problems compared to healthy individuals to help improve COVID-19 treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Aligos Therapeutics (Industry-sponsored)
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT06698549 on ClinicalTrials.gov

What this trial studies

This Phase 1, non-randomized, open-label study investigates the pharmacokinetics, safety, and tolerability of the drug ALG-097558 in individuals with severe renal impairment compared to healthy subjects with normal renal function. Participants will receive multiple doses of the medication, taken twice daily, while being matched for age, body weight, and gender. The primary goal is to understand how renal impairment affects the drug's behavior in the body. This study aims to provide critical data that could inform future treatment protocols for COVID-19 in patients with varying kidney functions.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 18 to 75 with either severe renal impairment or normal renal function.

Not a fit: Patients with significant comorbidities or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for COVID-19 patients with renal impairment.

How similar studies have performed: While this study explores a specific population, similar pharmacokinetic studies have shown promise in understanding drug effects in patients with renal impairment.

Eligibility criteria

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, gender
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 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

Where this trial is running

Miami, Florida and 2 other locations

• University of Miami — Miami, Florida, United States (Not_yet_recruiting)
• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Genesis Clinical Trials — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Jen Rito

Conditions COVID 19