Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Conditions

• Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) — DRUG
  100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) in 0.5 mL solution. Subcutaneous administration at Day 1
• Placebo — DRUG
  Inclisiran sodium 0mg (equivalent to inclisiran 0 mg) in 1.5 mL solution. Subcutaneous administration at Day 1
• 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) — DRUG
  300 mg inclisiran sodium (equivalent to 284 mg inclisiran) in 1.5 mL solution. Subcutaneous administration at Day 1

Study Details

Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with LDL-C lowering therapies

Key Dates

Start date

Feb 26, 2021

Status verified

Mar 2025

Primary completion

Oct 18, 2021

Completion

Oct 18, 2021

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 300 mg inclisiran sodium (equivalent to 284 mg inclisiran)
  300 mg inclisiran sodium (equivalent to 284 mg inclisiran) x 1 dose (n=15) at Day 1
• Experimental: 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran)
  100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) x 1 dose (n=15) at Day 1
• Placebo Comparator: Placebo
  Placebo x 1 dose (n=10) at Day 1

Primary Outcome Measure

PK parameters (Cmax) maximum peak observed plasma inclisiran concentration in treated participants [ Time Frame: 0-48 hours post-dose ]

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