Hypercholesterolemia
Conditions
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).
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUGplacebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests | Up to 12 weeks |
| Incidence of injection site reactions | Up to 4 days |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in LDL-C | Up to 12 weeks |
| Change from baseline in other lipid parameters | Up to 12 weeks |
| Pharmacokinetics: Assessment of serum concentrations of alirocumab | Up to 12 weeks |
| Pharmacokinetics: Assessment of serum concentrations of PCSK9 | Up to 12 weeks |
Countries
China
Outcome results
None listed