A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

April 4, 2025 updated by: Aligos Therapeutics
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Hammersmith Medicines Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALG-097558
Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days
Drug: ALG-097558
single or multiple doses of ALG-097558
Placebo Comparator: Placebo
Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days
Drug: Placebo
single or multiple doses of placebo
Experimental: ALG-097558 and Midazolam
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
Drug: ALG-097558
single or multiple doses of ALG-097558
Drug: Midazolam
Multiple doses of Midazolam
Experimental: ALG-097558, Placebo, and, Itraconazole
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.
Drug: Itraconazole
Multiple doses of Itraconazole
Drug: Placebo
single or multiple doses of placebo
Drug: ALG-097558
single or multiple doses of ALG-097558
Experimental: ALG-097558 and Carbamazepine
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
Drug: ALG-097558
single or multiple doses of ALG-097558
Drug: Carbamazepine
Multiple doses of Carbamazepine
Experimental: ALG-097558 Bioavailability
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
Drug: ALG-097558 in solution formulation
ALG-097558 in solution administered in fasted state
Drug: ALG-097558 in tablet formulation
ALG-097558 in tablet administered in fasted and fed state

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 11 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 11 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 20 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 20 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 20 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 20 days for Part 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 23 days for Part 4
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 23 days for Part 4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 28 days for Part 5
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 28 days for Part 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 17 days for Part 6
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Up to 17 days for Part 6
Area under the concentration time curve [AUC]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Time to maximum plasma concentration [Tmax]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Maximum plasma concentration [Cmax]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Minimum plasma concentration [Cmin]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
C0 [predose]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Half-life [t1/2]
Time Frame: Predose (-2 hours) up to 11 days
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Area under the concentration time curve [AUC]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
Maximum plasma concentration [Cmax]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
C0 [predose]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine
Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days
Time to maximum plasma concentration [Tmax]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days
Maximum plasma concentration [Cmax]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days
Minimum plasma concentration [Cmin]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days
C0 [predose]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days
Half-life [t1/2]
Time Frame: Predose (-0.75 hours) up to 9 days
Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet
Predose (-0.75 hours) up to 9 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration [Cmax]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
C0 [predose]
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days
Dose Proportionality
Time Frame: Predose (-0.75 hours) up to 19 days
Pharmacokinetic parameters of ALG-097558 in plasma
Predose (-0.75 hours) up to 19 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aligos Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALG-097558-701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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