HypercholesterolemiaPhase 1NCT01448317
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
A Phase 1 study testing Alirocumab (Solution) and Alirocumab (Lyophilized formulation) in people with Hypercholesterolemia, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Alirocumab (Solution) and Alirocumab (Lyophilized formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- May 2011to Jan 2012
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 pharmacodynamic (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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Read more
Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab 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 Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.
Read the detailed description
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
- Conditions
- Hypercholesterolemia
- Being tested
- Alirocumab (Solution), Alirocumab (Lyophilized formulation), Placebo (Solution), Placebo (Lyophilized formulation)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alirocumab (Solution)Drug
Also called SAR236553, REGN727
Pharmaceutical form: solution
Route of administration: subcutaneous
Alirocumab (Lyophilized formulation)Drug
Also called SAR236553, REGN727
Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
Placebo (Solution)Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
Placebo (Lyophilized formulation)Drug
Pharmaceutical form: lyophilized formulation
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Alirocumab dose 1 versus placebo Receives: Drug: Alirocumab (Lyophilized formulation); Drug: Placebo (Lyophilized formulation) |
| Cohort 2 | Experimental | Alirocumab dose 2 versus placebo Receives: Drug: Alirocumab (Lyophilized formulation); Drug: Placebo (Lyophilized formulation) |
| Cohort 3 | Experimental | Alirocumab dose 3 versus placebo Receives: Drug: Alirocumab (Lyophilized formulation); Drug: Placebo (Lyophilized formulation) |
| Cohort 4 | Experimental | Alirocumab dose 4 versus placebo Receives: Drug: Alirocumab (Solution); Drug: Placebo (Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Measured: 106 days
Secondary outcomes (3)
Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
Measured: 106 days
Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
Measured: 106 days
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.
Measured: 106 days
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 startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 32 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
- NCT01448317
- Sponsor's protocol ID
- TDU12190
- Other IDs
- U1111-1118-1213
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2011
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Teramoto T, Kobayashi M, Uno K, Takagi Y, Matsuoka O, Sugimoto M, Inoue S, Minami F, Baccara-Dinet MT. Efficacy and Safety of Alirocumab in Japanese Subjects (Phase 1 and 2 Studies). Am J Cardiol. 2016 Jul 1;118(1):56-63. doi: 10.1016/j.amjcard.2016.04.011. Epub 2016 Apr 21.
PubMed 27184170
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01448317
- Acronym / sponsor ID
- TDU12190
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (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:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab 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 Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.
Detailed description
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Alirocumab (Lyophilized formulation), Drug: Placebo (Lyophilized formulation)Alirocumab dose 1 versus placebo |
| Cohort 2 | Experimental | Drug: Alirocumab (Lyophilized formulation), Drug: Placebo (Lyophilized formulation)Alirocumab dose 2 versus placebo |
| Cohort 3 | Experimental | Drug: Alirocumab (Lyophilized formulation), Drug: Placebo (Lyophilized formulation)Alirocumab dose 3 versus placebo |
| Cohort 4 | Experimental | Drug: Alirocumab (Solution), Drug: Placebo (Solution)Alirocumab dose 4 versus placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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 pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
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 (Solution)Also: SAR236553, REGN727Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Cohort 4 |
| Alirocumab (Lyophilized formulation)Also: SAR236553, REGN727Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Placebo (Solution)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Cohort 4 |
| Placebo (Lyophilized formulation)Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of participants with Adverse Events
Time frame: 106 days
3 secondary outcomes
Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
Time frame: 106 days
Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
Time frame: 106 days
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
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 Sep 2016.
- Results publication: PubMed 27184170Teramoto T, Kobayashi M, Uno K, Takagi Y, Matsuoka O, Sugimoto M, Inoue S, Minami F, Baccara-Dinet MT. Efficacy and Safety of Alirocumab in Japanese Subjects (Phase 1 and 2 Studies). Am J Cardiol. 2016 Jul 1;118(1):56-63. doi: 10.1016/j.amjcard.2016.04.011. Epub 2016 Apr 21.
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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 (Solution) and Alirocumab (Lyophilized formulation) in people with Hypercholesterolemia, run by Sanofi at 1 site in Japan.
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 3 inclusion and 11 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 Sep 2016. 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 Japan. 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?
Number of participants with Adverse Events (time frame: 106 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448317, which also lists 1 linked publication.
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 Sep 2016.