Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects
2 other identifiers
interventional
32
1 country
1
Brief Summary
Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects. Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
- To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2011
Shorter than P25 for phase_1
1 active site
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
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedSeptember 28, 2016
September 1, 2016
8 months
September 21, 2011
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse Events
106 days
Secondary Outcomes (3)
Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
106 days
Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
106 days
Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.
106 days
Study Arms (4)
Cohort 1
EXPERIMENTALAlirocumab dose 1 versus placebo
Cohort 2
EXPERIMENTALAlirocumab dose 2 versus placebo
Cohort 3
EXPERIMENTALAlirocumab dose 3 versus placebo
Cohort 4
EXPERIMENTALAlirocumab dose 4 versus placebo
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous
Eligibility Criteria
You may qualify if:
- Healthy male subject, between 20 and 65 years inclusive.
- Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
- Serum LDL-C levels \>100 mg/dL
You may not qualify if:
- Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
- History or presence of drug or alcohol abuse
- Smoking more than 5 cigarettes or equivalent in any 24 hour period.
- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
- Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
- Presence or history of drug hypersensitivity
- Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
- Initiation of a new diet or major change to a previous diet within 4 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
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Sanofi-Aventis Administrative Office
Tokyo, Japan
Related Publications (1)
Teramoto T, Kobayashi M, Uno K, Takagi Y, Matsuoka O, Sugimoto M, Inoue S, Minami F, Baccara-Dinet MT. Efficacy and Safety of Alirocumab in Japanese Subjects (Phase 1 and 2 Studies). Am J Cardiol. 2016 Jul 1;118(1):56-63. doi: 10.1016/j.amjcard.2016.04.011. Epub 2016 Apr 21.
PMID: 27184170RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
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
September 21, 2011
First Posted
October 7, 2011
Study Start
May 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
September 28, 2016
Record last verified: 2016-09