A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979015
• Other study ID #: PKD13404
• Secondary ID: U1111-1133-7871
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2016
• Last updated: December 4, 2017
• Start date: November 29, 2016
• Est. completion date: November 27, 2017

Study information

• Verified date: December 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• alirocumab SAR236553 (REGN727)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
• placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of injection site reactions		Up to 4 days
Secondary	Change from baseline in LDL-C		Up to 12 weeks
Secondary	Change from baseline in other lipid parameters		Up to 12 weeks
Secondary	Pharmacokinetics: Assessment of serum concentrations of alirocumab		Up to 12 weeks
Secondary	Pharmacokinetics: Assessment of serum concentrations of PCSK9		Up to 12 weeks