Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: Healthy Volunteer
Lead sponsor: Aligos Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parts 1 and 2 of the study are parallel assignment, with 2 arms. Parts 3, 5, and 6 are fixed sequence, crossover studies. Part 4 is a partially placebo-controlled, fixed sequence, crossover study.
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 11 days for Part 1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 20 days for Part 2
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 20 days for Part 3
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 23 days for Part 4
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 28 days for Part 5
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 17 days for Part 6
measure: Area under the concentration time curve [AUC]
timeFrame: Predose (-2 hours) up to 11 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Predose (-2 hours) up to 11 days
measure: Maximum plasma concentration [Cmax]
timeFrame: Predose (-2 hours) up to 11 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Predose (-2 hours) up to 11 days
measure: C0 [predose]
timeFrame: Predose (-2 hours) up to 11 days
measure: Half-life [t1/2]
timeFrame: Predose (-2 hours) up to 11 days
measure: Area under the concentration time curve [AUC]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Maximum plasma concentration [Cmax]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: C0 [predose]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Half-life [t1/2]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Area under the concentration time curve [AUC]
timeFrame: Predose (-0.75 hours) up to 9 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Predose (-0.75 hours) up to 9 days
measure: Maximum plasma concentration [Cmax]
timeFrame: Predose (-0.75 hours) up to 9 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Predose (-0.75 hours) up to 9 days
measure: C0 [predose]
timeFrame: Predose (-0.75 hours) up to 9 days
measure: Half-life [t1/2]
timeFrame: Predose (-0.75 hours) up to 9 days
Secondary outcomes:
measure: Maximum plasma concentration [Cmax]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Area under the concentration time curve [AUC]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Half-life [t1/2]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: C0 [predose]
timeFrame: Predose (-0.75 hours) up to 19 days
measure: Dose Proportionality
timeFrame: Predose (-0.75 hours) up to 19 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
References: