Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979015
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: alirocumab SAR236553 (REGN727) Drug: placebo Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 29, 2016
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab
Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design
Drug: alirocumab SAR236553 (REGN727)

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous


Placebo Comparator: Placebo
Subcutaneous injection of a single dose of matching placebo
Drug: placebo

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979015


Locations
Layout table for location information
China
Investigational Site Number 156001
Beijing, China, 100191
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02979015    
Other Study ID Numbers: PKD13404
U1111-1133-7871 ( Other Identifier: UTN )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs