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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Aligos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2023-05-03
• Last updated: 2025-04-08

Locations

1 site across 1 country: United Kingdom