NCT06959888

A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Aligos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 single dose, open-label, randomized, two-period, two-sequence, crossover study of ALG-055009 conducted in 1 cohort of healthy volunteers. The primary purpose of this study is to compare the single-dose pharmacokinetics of the 0.7 mg dose level of 2 types of soft gelatin capsule formulations of ALG-055009, Formulation 1 and Formulation 2, in approximately 8 healthy volunteers.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	ALG-055009	Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 1) Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 2)

Timeline

• Start date: 2025-03-25
• Primary completion: 2025-05-08
• Completion: 2025-05-16
• First posted: 2025-05-07
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study