A Study to Assess the PK, PD, Safety and Tolerability of Eplontersen in Healthy Chinese Volunteers

Study identifier:D8450C00006

ClinicalTrials.gov identifier:NCT06527755

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1, Open-Label Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability of Eplontersen Following Subcutaneous Administration of a Single Dose in Healthy Chinese Volunteers

Medical condition

Transthyretin-mediated Amyloidosis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Eplontersen Solution for Injection

Sex

All

Actual Enrollment

12

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 06 Aug 2024
Estimated Primary Completion Date: 28 Oct 2024
Estimated Study Completion Date: 27 Dec 2024

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria