Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1133-7871 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.
Secondary Objectives:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alirocumab | Experimental | Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design |
|
| Placebo | Placebo Comparator | Subcutaneous injection of a single dose of matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab SAR236553 (REGN727) | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 156001 | Beijing | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32080823 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Up to 12 weeks |
| Pharmacokinetics: Assessment of serum concentrations of PCSK9 | Up to 12 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571059 | alirocumab |
Not provided
Not provided
Not provided