A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations
NCT06959888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-07-09
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
- 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)
Sponsors & Collaborators
-
Aligos Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-25
- Primary Completion
- 2025-05-08
- Completion
- 2025-05-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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