Ascending Dose Study of the Safety and Tolerability of SAR236553 (REGN727) in Japanese Healthy Volunteers
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01448317
First received: September 21, 2011
Last updated: May 22, 2012
Last verified: February 2012
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Purpose
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered SAR236553/REGN727 in Japanese healthy male subjects.
Secondary Objectives:
- To assess the Pharmacodynamics effect of a single SC dose of SAR236553/REGN727 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 Pharmacokinetics profile of a single SC dose of SAR236553/REGN727.
- To assess the immunogenicity of a single SC dose of SAR236553/REGN727.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: SAR236553/REGN727 (Solution) Drug: SAR236553/REGN727 (Lyophilized formulation) Drug: Placebo (Solution) Drug: Placebo (Lyophilized formulation) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 SAR236553 in Japanese Healthy Male Subjects |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of participants with Adverse Events [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit. [ Time Frame: 106 days ] [ Designated as safety issue: No ]
- Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit. [ Time Frame: 106 days ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 106 days ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | June 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Dose 1 versus placebo
|
Drug: SAR236553/REGN727 (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: subcutaneous
Drug: Placebo (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: Subcutaneous
|
|
Experimental: Cohort 2
Dose 2 versus placebo
|
Drug: SAR236553/REGN727 (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: subcutaneous
Drug: Placebo (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: Subcutaneous
|
|
Experimental: Cohort 3
Dose 3 versus placebo
|
Drug: SAR236553/REGN727 (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: subcutaneous
Drug: Placebo (Lyophilized formulation)
Pharmaceutical form:Lyophilized formulation Route of administration: Subcutaneous
|
|
Experimental: Cohort 4
Dose 4 versus placebo
|
Drug: SAR236553/REGN727 (Solution)
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: Placebo (Solution)
Pharmaceutical form:solution Route of administration: subcutaneous
|
Detailed Description:
The total duration of the study period per patient is 15 weeks (not including screening) broken down as follows:
Treatment: 1 day Follow-up: 15 weeks
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or PD half-life of that drug, whichever the longest; any vaccination within the last 28 days.
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01448317 History of Changes |
| Other Study ID Numbers: | TDU12190, U1111-1118-1213 |
| Study First Received: | September 21, 2011 |
| Last Updated: | May 22, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013