Clinical trial NCT01448239: Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2011-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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

Eligibility criteria: 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.

Primary outcomes:
measure: Pain using present pain intensity (PPI) verbal questionnaire
timeFrame: 6 weeks
measure: Erythema at injection site by measuring diameter and qualitative assessment
timeFrame: 6 weeks
measure: Edema at injection site by measuring diameter and qualitative assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of PK parameter - time to maximum concentration (tmax)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - maximum concentration (Cmax)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - area under curve (AUC)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - terminal elimination half-life (t1/2z)
timeFrame: Up to 12 weeks
measure: Pharmacodynamics: Change in LDL-C from baseline
timeFrame: Up to 12 weeks
measure: Number of participants with Adverse Events
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: