Skip to main content
OpenTrials
Completed

NCT Number: NCT05840952

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for All Subjects:

  • Male and Female between 18 and 55 years old
  • BMI 18.0 to 32.0 kg/m^2
  • Female subjects must have a negative serum pregnancy test at screening
  • Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

Exclusion criteria

for All Subjects:

  • 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
  • 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.
  • Subjects with a history of clinically significant drug allergy
  • Excessive use of alcohol defined as regular consumption of ≥14 units/week
  • Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
  • Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
  • 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)

Treatment and study plan

ALG-097558

Drug

single or multiple doses of ALG-097558

Placebo

Drug

single or multiple doses of placebo

midazolam

Drug

Multiple doses of Midazolam

Itraconazole

Drug

Multiple doses of Itraconazole

carbamazepine

Drug

Multiple doses of Carbamazepine

ALG-097558 in solution formulation

Drug

ALG-097558 in solution administered in fasted state

ALG-097558 in tablet formulation

Drug

ALG-097558 in tablet administered in fasted and fed state

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Area under the concentration time curve [AUC]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  8. Time to maximum plasma concentration [Tmax]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  9. Maximum plasma concentration [Cmax]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  10. Minimum plasma concentration [Cmin]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  11. C0 [predose]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  12. Half-life [t1/2]

    Time frame: Predose (-2 hours) up to 11 days

    Pharmacokinetic parameters of Midazolam and applicable metabolites

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

Secondary outcomes

  1. Maximum plasma concentration [Cmax]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  2. Area under the concentration time curve [AUC]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  3. Time to maximum plasma concentration [Tmax]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  4. Minimum plasma concentration [Cmin]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  5. Half-life [t1/2]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  6. C0 [predose]

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

  7. Dose Proportionality

    Time frame: Predose (-0.75 hours) up to 19 days

    Pharmacokinetic parameters of ALG-097558 in plasma

Sponsors and collaborators

Lead sponsor

Aligos Therapeutics

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.