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OpenTrials
Completed

NCT Number: NCT02979015

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 156001

Beijing, 100191, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alirocumab SAR236553 (REGN727)

Drug

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Placebo

Drug

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Primary outcomes

  1. Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests

    Time frame: Up to 12 weeks

  2. Incidence of injection site reactions

    Time frame: Up to 4 days

Secondary outcomes

  1. Change from baseline in LDL-C

    Time frame: Up to 12 weeks

  2. Change from baseline in other lipid parameters

    Time frame: Up to 12 weeks

  3. Pharmacokinetics: Assessment of serum concentrations of alirocumab

    Time frame: Up to 12 weeks

  4. Pharmacokinetics: Assessment of serum concentrations of PCSK9

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.