A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants
A Randomized Double-blind, Placebo-controlled, Non-confirmatory Study to Assess Safety, Tolerability, PK, and PD of Single Ascending and Multiple Doses of ISIS 681257 in Healthy Japanese Participants
Sponsor: Ionis Pharmaceuticals, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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
Secondary Endpoints
Maximum Observed Drug Concentration (Cmax) in Plasma After Single Ascending Dose of Pelacarsen
Area Under Curve (AUC) From Time Zero to the Last Quantifiable Concentration (AUClast) in Plasma After Single Ascending Dose of Pelacarsen
Maximum Observed Drug Concentration (Cmax) in Plasma After Multiple Doses of Pelacarsen
Eligibility Criteria
Inclusion Criteria: 1. Provided written informed consent (signed and dated) and any authorizations required by local law and was able to comply with all study requirements. 2. Male and female of first-, second- or third-generation Japanese participants. 3. Japanese healthy or obese male and female participants 18 to 65 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. 4. Participants weighed at least 45 kilograms (kg), healthy or obese with body mass index (BMI) ≤ 35.0 kilograms per meter square (kg/m\^2). 5. Participants had to have lipoprotein(a) (Lp\[a\]) ≥ 15 nanomole per liter (nmol/L) (8 milligram per deciliter \[mg/dL\]) at screening. Exclusion Criteria: 1. Clinically significant abnormalities in medical history including acute coronary syndrome, major surgery within 3 months of screening, planned surgery that would have occurred during the study or physical examination o…
Read full criteria on CT.gov →✦ Analyst Commentary
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