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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

NCT05840952 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-08

No results posted yet for this 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

Conditions

Interventions

DRUG

ALG-097558

single or multiple doses of ALG-097558

DRUG

Placebo

single or multiple doses of placebo

DRUG

Midazolam

Multiple doses of Midazolam

DRUG

Itraconazole

Multiple doses of Itraconazole

DRUG

Carbamazepine

Multiple doses of Carbamazepine

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

Sponsors & Collaborators

  • Aligos Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2024-04-29
Completion
2024-04-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05840952 on ClinicalTrials.gov