The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese participants.
This was a randomized, placebo-controlled, participant and investigator-blinded, single ascending and multiple-dose study of Pelacrsen (ISIS 681257) in up to 29 healthy Japanese male and female participants. The study was conducted in two parts:1) Single ascending dose (SAD) including up to a 28-day screening period, a baseline period, dose with study drug on Day 1, a 2-day (48 hours) post-dose in-patient observation period, followed by an out-patient observation period up to Day 90; 2) Multiple doses (MD) including up to a 28-day screening period, a baseline period, dose with study drug up to Day 85, a 2-day (48 hours) post-dose in-patient observation period, followed by an out-patient observation period up to Day 204. In the SAD period, participants were randomized to receive single dose of Pelacarsen or placebo. Upon completion of the SAD period participants were randomized to receive multiple doses of Pelacarsen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
29
Pelacarsen-matching placebo administered by SC injection.
Pelacarsen administered by SC injection.
Parexel International
Glendale, California, United States
SAD: Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Evaluation Parameters
Time frame: Up to Day 90
SAD: Percentage of Participants With Adverse Events
Time frame: Up to Day 90
SAD: Percentage of Participants With Serious Adverse Events
Time frame: Up to Day 90
MAD: Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Evaluation Parameters
Time frame: Up to Day 204
MAD: Percentage of Participants With Adverse Events
Time frame: Up to Day 204
MAD: Percentage of Participants With Serious Adverse Events
Time frame: Up to Day 204
Maximum Observed Drug Concentration (Cmax) in Plasma After Single Ascending Dose of Pelacarsen
Time frame: Day 1: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 up to 168 hours post-dose
Area Under Curve (AUC) From Time Zero to the Last Quantifiable Concentration (AUClast) in Plasma After Single Ascending Dose of Pelacarsen
Time frame: Day 1: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 up to 168 hours post-dose
Maximum Observed Drug Concentration (Cmax) in Plasma After Multiple Doses of Pelacarsen
Time frame: Days 1 and 85: Pre-dose; 1, 2, 4, 8, 24 up to 168 hours post-dose
Area Under Curve (AUC) From Time Zero to the Last Quantifiable Concentration (AUClast) in Plasma After Multiple Doses of Pelacarsen
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Time frame: Days 1 and 85: Pre-dose; 1, 2, 4, 8, 24 up to 168 hours post-dose