NCT02979015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

November 29, 2016

Last Update Submit

December 4, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • 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

    Up to 12 weeks

  • Pharmacokinetics: Assessment of serum concentrations of PCSK9

    Up to 12 weeks

Study Arms (2)

Alirocumab

EXPERIMENTAL

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

Drug: alirocumab SAR236553 (REGN727)

Placebo

PLACEBO COMPARATOR

Subcutaneous injection of a single dose of matching placebo

Drug: placebo

Interventions

alirocumab SAR236553 (REGN727)DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Alirocumab
placeboDRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects.
  • Aged 18 to 45 years old.
  • Low-density lipoprotein cholesterol \>100 mg/dL (2.59 mmol/L).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 156001

Beijing, 100191, China

Location

Related Publications (1)

  • 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.

    PMID: 32080823DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

November 29, 2016

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

CN(1)