NCT04774003View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 26, 2021

Primary Completion Date

October 18, 2021

Study Completion Date

October 18, 2021

Conditions
Hyperlipidemia
Interventions
DRUG

100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran)

100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) in 0.5 mL solution. Subcutaneous administration at Day 1

DRUG

Placebo

Inclisiran sodium 0mg (equivalent to inclisiran 0 mg) in 1.5 mL solution. Subcutaneous administration at Day 1

DRUG

300 mg inclisiran sodium (equivalent to 284 mg inclisiran)

300 mg inclisiran sodium (equivalent to 284 mg inclisiran) in 1.5 mL solution. Subcutaneous administration at Day 1

Trial Locations (3)

100029

Novartis Investigative Site, Beijing

410003

Novartis Investigative Site, Changsha

610041

Novartis Investigative Site, Chengdu

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY