HealthyPhase 1NCT01537653
Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
A Phase 1 study testing SAR231893 (REGN668) in people with Healthy, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects Secondary Objectives: Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects The pharmacokinetics of… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAR231893 (REGN668)
- 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
- Mar 2012to Oct 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese adult male subjects, between 20 and 45 years of age, inclusive.
- Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment.
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- Any subject who cannot prohibit intensive physical activity throughout the study duration.
- Positive result on 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.
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Serum alcohol level over the upper limit of normal range (ULN).
- Previous exposure to any therapeutic or investigational biological agent.
- 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 Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Subcutaneous Doses of SAR231893/REGN668 in Healthy Japanese Adult Male Subjects
Primary Objective:
Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects
Secondary Objectives:
Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects
- The pharmacokinetics of SAR231893 (REGN668)
- The immunogenicity of SAR231893 (REGN668)
- Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)
Read the detailed description
Total duration of the study period per subject is 11 weeks broken down as follows:
Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day
- Conditions
- Healthy
- Being tested
- SAR231893 (REGN668), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR231893 (REGN668)Drug
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
placeboDrug
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SAR231893 (REGN668), Dose Level 4 | Experimental | Dose Level 4 Receives: Drug: SAR231893 (REGN668) |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
| SAR231893 (REGN668), Dose Level 1 | Experimental | Dose Level 1 Receives: Drug: SAR231893 (REGN668) |
| SAR231893 (REGN668), Dose Level 2 | Experimental | Dose Level 2 Receives: Drug: SAR231893 (REGN668) |
| SAR231893 (REGN668), Dose Level 3 | Experimental | Dose Level 3 Receives: Drug: SAR231893 (REGN668) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)
Measured: Up to 57 days
Secondary outcomes (2)
Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time
Measured: Up to 57 days
Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Measured: Up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 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 HealthyStudies 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
- NCT01537653
- Sponsor's protocol ID
- TDU12265
- Other IDs
- U1111-1127-2719
- Status last verified
- Nov 2012
- First submitted
- 17 Feb 2012
- Last updated
- 6 Dec 2013
- Results posted
- No
Publications
Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.
PubMed 32348036
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Subcutaneous Doses of SAR231893/REGN668 in Healthy Japanese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01537653
- Acronym / sponsor ID
- TDU12265
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Feb 2012 (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:
Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects
Secondary Objectives:
Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects
- The pharmacokinetics of SAR231893 (REGN668)
- The immunogenicity of SAR231893 (REGN668)
- Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)
Detailed description
Total duration of the study period per subject is 11 weeks broken down as follows:
Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SAR231893 (REGN668), Dose Level 4 | Experimental | Drug: SAR231893 (REGN668)Dose Level 4 |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
| SAR231893 (REGN668), Dose Level 1 | Experimental | Drug: SAR231893 (REGN668)Dose Level 1 |
| SAR231893 (REGN668), Dose Level 2 | Experimental | Drug: SAR231893 (REGN668)Dose Level 2 |
| SAR231893 (REGN668), Dose Level 3 | Experimental | Drug: SAR231893 (REGN668)Dose Level 3 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese adult male subjects, between 20 and 45 years of age, inclusive.
- Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment.
- Having given written informed consent prior to undertaking any study-related procedure.
Key exclusion criteria (7 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- Any subject who cannot prohibit intensive physical activity throughout the study duration.
- Positive result on 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.
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Serum alcohol level over the upper limit of normal range (ULN).
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 |
|---|---|---|
| SAR231893 (REGN668)Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection | Drug | SAR231893 (REGN668), Dose Level 1, SAR231893 (REGN668), Dose Level 2, SAR231893 (REGN668), Dose Level 3, SAR231893 (REGN668), Dose Level 4 |
| placeboPharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection | Drug | Placebo |
Primary outcome
Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)
Time frame: Up to 57 days
2 secondary outcomes
Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time
Time frame: Up to 57 days
Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Time frame: Up to 57 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 6 Dec 2013.
- Derived from this study: PubMed 32348036Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.
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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 SAR231893 (REGN668) in people with Healthy, 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 4 inclusion and 7 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 6 Dec 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 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. Some participants in this study may receive a placebo. 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 subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests) (time frame: Up to 57 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 NCT01537653, 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 6 Dec 2013.