Clinical trial NCT02979015: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2016-12-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.

Secondary Objectives:

* To assess the pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters.
* To assess the immunogenicity of a single SC dose of alirocumab.

Detailed description: Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).

Eligibility criteria: Inclusion criteria:

* Healthy male or female subjects.
* Aged 18 to 45 years old.
* Low-density lipoprotein cholesterol \>100 mg/dL (2.59 mmol/L).

Exclusion criteria:

* Subjects with any history or presence of clinically relevant illness.
* Serum triglycerides \>200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests
timeFrame: Up to 12 weeks
measure: Incidence of injection site reactions
timeFrame: Up to 4 days
Secondary outcomes:
measure: Change from baseline in LDL-C
timeFrame: Up to 12 weeks
measure: Change from baseline in other lipid parameters
timeFrame: Up to 12 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of alirocumab
timeFrame: Up to 12 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of PCSK9
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Li H, Wei Y, Yang Z, Zhang S, Xu X, Shuai M, Vitse O, Wu Y, Baccara-Dinet MT, Zhang Y, Li J. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study. Am J Cardiovasc Drugs. 2020 Oct;20(5):489-503. doi: 10.1007/s40256-020-00394-1.