A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05579860
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Olezarsen — DRUG
    Olezarsen will be administered by SC injection.

Study Details

The purpose of the study is to assess the bioequivalence of olezarsen between 2 subcutaneous (SC) formulations \[(autoinjector (AI) and vial\] at 2 dose levels in healthy adult participants.

Key Dates

Start date
Oct 5, 2022
Status verified
May 2024
Primary completion
May 22, 2023
Completion
May 22, 2023

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Olezarsen Dose Level 1
    Participants will receive two doses of Dose Level 1 each, using one of the following two sequences: (i) AI on Day 1 of Treatment Period 1, followed by vial on Day 1 of Treatment Period 2; or (ii) vial on Day 1 of Treatment Period 1, followed by AI on Day 1 of Treatment Period 2. A washout period of 28-42 days will be maintained between the 2 treatment periods.
  • Experimental: Olezarsen Dose Level 2
    Participants will receive two doses of Dose Level 2 each, using one of the following two sequences: (i) AI on Day 1 of Treatment Period 1, followed by vial on Day 1 of Treatment Period 2; or (ii) vial on Day 1 of Treatment Period 1, followed by AI on Day 1 of Treatment Period 2 A washout period of at least 28 days will be maintained between the 2 treatment periods.

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC) of olezarsen from time 0 to 336 hours (AUC0-336h) [ Time Frame: Up to Day 8 of each of Treatment Periods 1 and 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medpace Clinical Pharmacology UnitCincinnatiOhio45227-

Find similar trials in Cincinnati, OH

By research site
Medpace Clinical Pharmacology Unit· Cincinnati, OH

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