NCT05579860

A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

A Single-Dose, Randomized, Open-Label, Two-Period Crossover, Bioequivalence Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the bioequivalence of olezarsen between 2 subcutaneous (SC) formulations \[(autoinjector (AI) and vial\] at 2 dose levels in healthy adult participants.

Detailed description

This is a Phase 1, single-dose, randomized, open-label, two-period, crossover study in approximately 100 healthy participants. The study will consist of an up to 28-day Screening Period, two treatment periods of 15 days each - with the second treatment period starting 28-42 days after the first begins - and a Post-Treatment Follow-Up Period lasting 91 days after the second treatment period begins. Eligible participants will be randomized to two dose groups (50 mg or 80 mg olezarsen). Participants will be dosed once at the beginning of each treatment period, one time using a single-use AI and one time using a single-use vial. Within each dose group, approximately half of the participants will be dosed with the AI first, with the other participants being dosed with the vial first.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Olezarsen	Olezarsen will be administered by SC injection.

Timeline

• Start date: 2022-10-05
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2022-10-14
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study