A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

Aligos Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: COVID-19

Treatments: Drug: ALG-097558 in solution formulation; Drug: Placebo; Drug: ALG-097558 in tablet formulation; Drug: Midazolam; Drug: ALG-097558; Drug: Itraconazole; Drug: Carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05840952

ALG-097558-701

Details and patient eligibility

About

A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for All Subjects:

1. Male and Female between 18 and 55 years old
2. BMI 18.0 to 32.0 kg/m^2
3. Female subjects must have a negative serum pregnancy test at screening
4. Subjects must have a 12-lead electrocardiogram (ECG) that meets 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' 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 or unstable cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Excessive use of alcohol defined as regular consumption of ≥14 units/week
5. Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
6. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
7. Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 6 patient groups, including a placebo group

ALG-097558

Experimental group

Description:

Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days

Treatment:

Drug: ALG-097558

Placebo

Placebo Comparator group

Description:

Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days

Treatment:

Drug: Placebo

ALG-097558 and Midazolam

Experimental group

Description:

Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers

Treatment:

Drug: ALG-097558

Drug: Midazolam

ALG-097558, Placebo, and, Itraconazole

Experimental group

Description:

Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.

Treatment:

Drug: Itraconazole

Drug: ALG-097558

Drug: Placebo

ALG-097558 and Carbamazepine

Experimental group

Description:

Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers

Treatment:

Drug: Carbamazepine

Drug: ALG-097558

ALG-097558 Bioavailability

Experimental group

Description:

Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers

Treatment:

Drug: ALG-097558 in tablet formulation

Drug: ALG-097558 in solution formulation