Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448239
• Other study ID #: PKD12010
• Secondary ID: U1111-1118-2935
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2011
• Last updated: June 27, 2013
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

Injection Site Tolerability

Secondary Objectives:

• To assess the safety profile of alirocumab SAR236553 (REGN727)

• To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

Description:

The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Serum troponin I level should not exceed the upper laboratory limit of normal.

• Male or female subject, between 18 and 65 years inclusive.

• Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.

• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

• Normal vital signs after 10 minutes resting in supine position.

• Normal standard 12-lead ECG after 10 minutes resting in supine position.

• Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects

• If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

• Serum LDL-C levels>100 mg/dL at screening visit.

Exclusion criteria:

• Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).

• Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). Subjects must be willing to maintain a consistent diet for the duration of the study.

• Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.

• Fasting serum triglycerides >200 mg/dL measured after an 8 to 12 hour fast.

• History of a hypersensitivity reaction to doxycycline or similar compound.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous
• alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using present pain intensity (PPI) verbal questionnaire		6 weeks	Yes
Primary	Erythema at injection site by measuring diameter and qualitative assessment		6 weeks	Yes
Primary	Edema at injection site by measuring diameter and qualitative assessment		6 weeks	Yes
Secondary	Assessment of PK parameter - time to maximum concentration (tmax)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - maximum concentration (Cmax)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - area under curve (AUC)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - terminal elimination half-life (t1/2z)		Up to 12 weeks	No
Secondary	Pharmacodynamics: Change in LDL-C from baseline		Up to 12 weeks	No
Secondary	Number of participants with Adverse Events		Up to 12 weeks	Yes