HypercholesterolemiaPhase 1NCT01448239
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 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 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
About this study
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
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
- 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
alirocumab SAR236553 (REGN727)Drug
Pharmaceutical form:Solution Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| alirocumab SAR236553 (REGN727) - Dose A | Experimental | A single subcutaneous injection of Dose A Receives: Drug: alirocumab SAR236553 (REGN727) |
| alirocumab SAR236553 (REGN727) - Dose B | Experimental | A single subcutaneous injection of Dose B 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
Measured: 6 weeks
Erythema at injection site by measuring diameter and qualitative assessment
Measured: 6 weeks
Edema at injection site by measuring diameter and qualitative assessment
Measured: 6 weeks
Secondary outcomes (7)
Assessment of PK parameter - time to maximum concentration (tmax)
Measured: Up to 12 weeks
Assessment of PK parameter - maximum concentration (Cmax)
Measured: Up to 12 weeks
Assessment of PK parameter - area under curve (AUC)
Measured: Up to 12 weeks
Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)
Measured: Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Measured: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Measured: Up to 12 weeks
Number of participants with Adverse Events
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 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
- 24 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
- NCT01448239
- Sponsor's protocol ID
- PKD12010
- Other IDs
- U1111-1118-2935
- Status last verified
- Feb 2012
- First submitted
- 5 Oct 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
- Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
- ClinicalTrials.gov ID
- NCT01448239
- Acronym / sponsor ID
- PKD12010
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Oct 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
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alirocumab SAR236553 (REGN727) - Dose A | Experimental | Drug: alirocumab SAR236553 (REGN727)A single subcutaneous injection of Dose A |
| alirocumab SAR236553 (REGN727) - Dose B | Experimental | Drug: alirocumab SAR236553 (REGN727)A single subcutaneous injection of Dose B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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) - Dose A |
| alirocumab SAR236553 (REGN727)Pharmaceutical form:Solution Route of administration: Subcutaneous | Drug | alirocumab SAR236553 (REGN727) - Dose B |
Primary outcome
Pain using present pain intensity (PPI) verbal questionnaire
Time frame: 6 weeks
Erythema at injection site by measuring diameter and qualitative assessment
Time frame: 6 weeks
Edema at injection site by measuring diameter and qualitative assessment
Time frame: 6 weeks
7 secondary outcomes
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 12 weeks
Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)
Time frame: Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Time frame: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 12 weeks
Number of participants with Adverse Events
Time frame: Up to 12 weeks
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 9 inclusion and 6 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 (time frame: 6 weeks). 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.