A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)

Sponsor
Amgen
Study ID
NCT04987320
Phase
PHASE1
Status
Completed

Conditions

  • Elevated Serum Lipoprotein(a)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp\[a\]).

Key Dates

Start date
Jul 28, 2021
Status verified
Jan 2025
Primary completion
Nov 12, 2021
Completion
Mar 18, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Olpasiran Dose A
    Participants will be administered Olpasiran dose A as a subcutaneous injection.
  • Experimental: Olpasiran Dose B
    Participants will be administered Olpasiran dose B as a subcutaneous injection.

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of Olpasiran [ Time Frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85 ]

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