HypercholesterolemiaPhase 1NCT01443650
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects
A Phase 1 study testing alirocumab SAR236553 (REGN727) in people with Hypercholesterolemia, run by Sanofi at 1 site in United States.
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) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- alirocumab SAR236553 (REGN727)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Serum LDL-C levels >100 mg/dL.
Who cannot join
- Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.
- Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. 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, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.
- Fasting serum triglycerides >200 mg/dL measured after an 8-12 hour fast.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
About this study
Official title: A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy Subjects
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)
Read the detailed description
Total duration for each subject (not including screening) will be approximately 85 days.
- Conditions
- Hypercholesterolemia
- Being tested
- alirocumab SAR236553 (REGN727)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alirocumab SAR236553 (REGN727)Drug
Pharmaceutical form:solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| alirocumab SAR236553 (REGN727) (Formulation A x 1) | Experimental | A single subcutaneous injection of Formulation A Receives: Drug: alirocumab SAR236553 (REGN727) |
| alirocumab SAR236553 (REGN727) (Formulation B x 1) | Experimental | A single subcutaneous injection of Formulation B Receives: Drug: alirocumab SAR236553 (REGN727) |
| alirocumab SAR236553 (REGN727) (Formulation A x 2) | Experimental | 2 single subcutaneous injections of Formulation A Receives: Drug: alirocumab SAR236553 (REGN727) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
Measured: 15 days
Erythema at injection site by measuring diameter and qualitative assessment
Measured: 15 days
Edema at injection site by measuring diameter and qualitative assessment
Measured: 15 days
Secondary outcomes (8)
Assessment of PK parameter - time to maximum concentration (tmax)
Measured: Up to 85 days
Pharmacodynamics: Change in LDL-C from baseline
Measured: Up to 85 days
Number of participants with Adverse Events
Measured: Up to 85 days
Assessment of PK parameter - maximum concentration (Cmax)
Measured: Up to 85 days
Assessment of PK parameter - area under curve (AUC)
Measured: Up to 85 days
Assessment of PK parameter - area under curve versus time curve (AUC0-D29)
Measured: Zero to Day 29
Assessment of PK parameter - plasma concentration on Day 29 (C D29)
Measured: Day 29
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Measured: Up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443650
- Sponsor's protocol ID
- PKD12275
- Other IDs
- U1111-1120-0670
- Status last verified
- Feb 2012
- First submitted
- 21 Sep 2011
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01443650
- Acronym / sponsor ID
- PKD12275
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Total duration for each subject (not including screening) will be approximately 85 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alirocumab SAR236553 (REGN727) (Formulation A x 1) | Experimental | Drug: alirocumab SAR236553 (REGN727)A single subcutaneous injection of Formulation A |
| alirocumab SAR236553 (REGN727) (Formulation B x 1) | Experimental | Drug: alirocumab SAR236553 (REGN727)A single subcutaneous injection of Formulation B |
| alirocumab SAR236553 (REGN727) (Formulation A x 2) | Experimental | Drug: alirocumab SAR236553 (REGN727)2 single subcutaneous injections of Formulation A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Serum LDL-C levels >100 mg/dL.
Key exclusion criteria (5 listed)
- Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.
- Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. 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, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.
- Fasting serum triglycerides >200 mg/dL measured after an 8-12 hour fast.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alirocumab SAR236553 (REGN727)Pharmaceutical form:solution Route of administration: subcutaneous | Drug | alirocumab SAR236553 (REGN727) (Formulation A x 1), alirocumab SAR236553 (REGN727) (Formulation A x 2), alirocumab SAR236553 (REGN727) (Formulation B x 1) |
Primary outcome
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
Time frame: 15 days
Erythema at injection site by measuring diameter and qualitative assessment
Time frame: 15 days
Edema at injection site by measuring diameter and qualitative assessment
Time frame: 15 days
8 secondary outcomes
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 85 days
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 85 days
Number of participants with Adverse Events
Time frame: Up to 85 days
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 85 days
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 85 days
Assessment of PK parameter - area under curve versus time curve (AUC0-D29)
Time frame: Zero to Day 29
Assessment of PK parameter - plasma concentration on Day 29 (C D29)
Time frame: Day 29
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Time frame: Up to 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alirocumab SAR236553 (REGN727) in people with Hypercholesterolemia, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS) (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.