A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Healthy Japanese Participants
- Registration Number
- NCT04302064
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
To evaluate the safety and tolerability of single and potentially multiple doses of Eplontersen administered subcutaneously (SC) to healthy Japanese participants.
- Detailed Description
This is a single-center, double-blinded, placebo-controlled study in up to 44 participants. Participants will be randomized to receive three subcutaneous single-ascending doses and potentially multiple doses of Eplontersen or placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Single dose on Day 1 or multiple doses (every 4 weeks for 12 weeks) of Eplontersen-matching placebo administered SC. Eplontersen Eplontersen Single dose on Day 1 or multiple doses (every 4 weeks for 12 weeks) of Eplontersen administered SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Changes in Clinically Significant (CS) Laboratory Value Abnormalities Up to 92 days Percentage of Participants with at Least One Treatment-emergent Adverse Event (TEAE), Graded by Severity Up to 92 days Percentage of Participants with TEAEs Potentially Related to Study Drug Up to 92 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
WCCT Global
🇺🇸Cypress, California, United States