A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

Part of paid clinical trials in Glendale, California.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05337878
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Pelacarsen-matching placebo administered by SC injection.
  • Pelacarsen — DRUG
    Pelacarsen administered by SC injection.

Study Details

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.

Key Dates

Start date
Oct 15, 2018
Status verified
Apr 2022
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Placebo Comparator: SAD: Placebo
    Single dose of Pelacarsen-matching placebo administered by SC injection on Day 1 of single-dose treatment period.
  • Experimental: SAD: Pelacarsen 20 milligrams (mg)
    Single dose of Pelacarsen, 20 mg, administered by SC injection on Day 1 of single-dose treatment period.
  • Experimental: SAD: Pelacarsen 40 mg
    Single dose of Pelacarsen, 40 mg, administered by SC injection on Day 1 of single-dose treatment period.
  • Experimental: SAD: Pelacarsen 80 mg
    Single dose of Pelacarsen, 80 mg, administered by SC injection on Day 1 of single-dose treatment period.
  • Placebo Comparator: MD: Placebo
    Multiple doses of Pelacarsen-matching placebo administered by SC injection every 4 weeks, on Days 1, 29, 57 and 85 of multiple-dose treatment period.
  • Experimental: MD: Pelacarsen 80 mg
    Multiple doses of Pelacarsen, 80 mg, administered by SC injection every 4 weeks, on Days 1, 29, 57 and 85 of multiple-dose treatment period.

Primary Outcome Measure

SAD: Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Evaluation Parameters [ Time Frame: Up to Day 90 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Parexel InternationalGlendaleCalifornia91206-

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Parexel International· Glendale, CA

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