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

Last updated: April 4, 2025
Sponsor: Aligos Therapeutics
Overall Status: Completed

Phase

1

Condition

Covid-19

Treatment

Midazolam

ALG-097558 in solution formulation

ALG-097558

Clinical Study ID

NCT05840952
ALG-097558-701
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 Design

Total Participants: 90
Treatment Group(s): 7
Primary Treatment: Midazolam
Phase: 1
Study Start date:
July 04, 2023
Estimated Completion Date:
April 29, 2024

Connect with a study center

  • Hammersmith Medicines Research

    London,
    United Kingdom

    Site Not Available

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