HealthyPhase 1NCT00856310
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
A Phase 1 study testing REGN475 (SAR164877) in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REGN475 (SAR164877)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2009
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers, in general good health and 21 to 65 years of age.
- Female volunteers must be post-menopausal for at least 1 year or surgically sterile.
Who cannot join
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
- Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.
- Conditions
- Healthy
- Being tested
- REGN475 (SAR164877)
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN475 (SAR164877)Biological
Subcutaneous administration REGN475 (SAR164877)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Dose 1 REGN475 Receives: Biological: REGN475 (SAR164877) |
| Cohort 2 | Active comparator | Dose 2 of REGN475 Receives: Biological: REGN475 (SAR164877) |
| Cohort 3 | Active comparator | Dose 2 of REGN475 Receives: Biological: REGN475 (SAR164877) |
| Cohort 4 | Active comparator | Dose 1 of REGN475 Receives: Biological: REGN475 (SAR164877) |
| Cohort 5 | Active comparator | Dose 2 of REGN475 Receives: Biological: REGN475 (SAR164877) |
| Cohort 6 | Active comparator | Dose 1 REGN475 subcutaneous administration Receives: Biological: REGN475 (SAR164877) |
| Cohort 7 | Active comparator | Dose 2 REGN475 subcutaneous administration Receives: Biological: REGN475 (SAR164877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
Measured: 16 weeks
Secondary outcomes (2)
Serum concentrations of REGN475.
Measured: 16 Weeks
The presence or absence of antibodies against REGN475.
Measured: 16 Week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856310
- Sponsor's protocol ID
- R475-PN-0817
- Status last verified
- May 2012
- First submitted
- 12 Feb 2009
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00856310
- Acronym / sponsor ID
- R475-PN-0817
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Mar 2009 (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.
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Biological: REGN475 (SAR164877)Dose 1 REGN475 |
| Cohort 2 | Active comparator | Biological: REGN475 (SAR164877)Dose 2 of REGN475 |
| Cohort 3 | Active comparator | Biological: REGN475 (SAR164877)Dose 2 of REGN475 |
| Cohort 4 | Active comparator | Biological: REGN475 (SAR164877)Dose 1 of REGN475 |
| Cohort 5 | Active comparator | Biological: REGN475 (SAR164877)Dose 2 of REGN475 |
| Cohort 6 | Active comparator | Biological: REGN475 (SAR164877)Dose 1 REGN475 subcutaneous administration |
| Cohort 7 | Active comparator | Biological: REGN475 (SAR164877)Dose 2 REGN475 subcutaneous administration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female volunteers, in general good health and 21 to 65 years of age.
- Female volunteers must be post-menopausal for at least 1 year or surgically sterile.
Key exclusion criteria (2 listed)
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
- Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
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 |
|---|---|---|
| REGN475 (SAR164877)Subcutaneous administration REGN475 (SAR164877) | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
Time frame: 16 weeks
2 secondary outcomes
Serum concentrations of REGN475.
Time frame: 16 Weeks
The presence or absence of antibodies against REGN475.
Time frame: 16 Week follow up
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 10 May 2012.
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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 Trial Management study director
Regeneron Pharmaceuticals
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 REGN475 (SAR164877) in people with Healthy, run by Regeneron Pharmaceuticals 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 2 inclusion and 2 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 10 May 2012. 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?
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. (time frame: 16 weeks). 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 10 May 2012.