Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527755
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
A Study to Assess the PK PD Safety and Tolerability of Eplontersen in Healthy Chinese Volunteers
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 study to assess the pharmacokinetics PK pharmacodynamics PD safety and tolerability of eplontersen following single dosing in healthy Chinese participants The objectives of the study are to characterize the pharmacokinetic PK profiles and the pharmacodynamic PD profiles and to evaluate the safety and tolerability and the immunogenicity of eplontersen following subcutaneous administration of a single 45 mg dose in healthy Chinese participants
Detailed Description:
This is a Phase 1 open-label single-dose single-arm study to assess the pharmacokinetics PK pharmacodynamics PD safety and tolerability of eplontersen following subcutaneous SC administration in healthy Chinese male and female participants Approximately 12 healthy Chinese participants aged 18 to 60 years will be assigned to study intervention of a signle dose of eplontersen 45 mg following subcutaneous administration Including the administration dosing day the follow-up period is total of 92 days The primary objective of this study is to characterize the PK profile of eplontersen the PK parameters for eplontersen including but not limited to Cmax tmax t½λz AUC0-24h and AUC0-168h The secondary objective of this study is to characterize the PD profiles of eplontersen this includes the measures of change and percent change from baseline in serum TTR levels at specified timepoints The safety objective of this study is to evaluate the safety and tolerability of eplontersen this includes the measures of AEsSAEs vital signs physical examinations safety laboratory assessments and 12-lead ECG Also the exploratory objective of this study is to evaluate the immunogenicity of eplontersen this includes the measures of but not limited to anti-drug antibodies ADA prevalence and incidence different ADA status at specified timepoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None