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

NCT ID: NCT02979015

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2017-11-27

Brief Summary

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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

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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).

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alirocumab

Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Placebo

Subcutaneous injection of a single dose of matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Interventions

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alirocumab SAR236553 (REGN727)

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

placebo

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 156001

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32080823 (View on PubMed)

Other Identifiers

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U1111-1133-7871

Identifier Type: OTHER

Identifier Source: secondary_id

PKD13404

Identifier Type: -

Identifier Source: org_study_id