HealthyPhase 1NCT01537640
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
A Phase 1 study testing SAR231893 (REGN668) DP1 and SAR231893 (REGN668) DP2 in people with Healthy, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAR231893 (REGN668) DP1 and SAR231893 (REGN668) DP2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between 18 and 45 years of age
Who cannot join
- Presence or history of drug hypersensitivity or allergic disease
- History or presence of dermatological disorders
- Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
- Prior opportunistic infections within 6 months before inclusion
- History or presence of listeriosis or tuberculosis
- Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
Show all 9Show fewer
- Any biologics given within 4 months before inclusion
- Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening
- The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site Number 840001
Daytona Beach, Florida, 32117
About this study
Official title: A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects
Primary Objective:
To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose
Secondary Objective:
To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
Read the detailed description
The duration of the study for each subject is 8-11 weeks broken down as follows:
- Screening: 2 to 21 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 2 months after dosing.
- Conditions
- Healthy
- Being tested
- SAR231893 (REGN668) DP1, SAR231893 (REGN668) DP2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR231893 (REGN668) DP1Biological
Pharmaceutical form:solution Route of administration: subcutaneous
SAR231893 (REGN668) DP2Biological
Pharmaceutical form:solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR231893 (REGN668) Drug Product (DP) 1 | Experimental | SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection Receives: Biological: SAR231893 (REGN668) DP1 |
| SAR231893 (REGN668) Drug Product (DP) 2 | Experimental | SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection Receives: Biological: SAR231893 (REGN668) DP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum concentrations of SAR231893 (REGN668)
Measured: Up to 57 Days
Secondary outcomes (4)
Pain evaluation at injection site using Visual Analog Scale (VAS)
Measured: Up to 8 Days
Erythema at injection site by measuring diameter
Measured: Up to 8 Days
Edema at injection site by measuring diameter
Measured: Up to 8 Days
Number of participants experiencing adverse events
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 startFeb 2012
- Primary completionJul 2012
- Study completionJul 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
- 30 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
- NCT01537640
- Sponsor's protocol ID
- PKM12350
- Other IDs
- U1111-1119-3152
- Status last verified
- Jul 2012
- First submitted
- 17 Feb 2012
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- 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, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects
- ClinicalTrials.gov ID
- NCT01537640
- Acronym / sponsor ID
- PKM12350
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 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:
To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose
Secondary Objective:
To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
Detailed description
The duration of the study for each subject is 8-11 weeks broken down as follows:
- Screening: 2 to 21 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 2 months after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR231893 (REGN668) Drug Product (DP) 1 | Experimental | Biological: SAR231893 (REGN668) DP1SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection |
| SAR231893 (REGN668) Drug Product (DP) 2 | Experimental | Biological: SAR231893 (REGN668) DP2SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects between 18 and 45 years of age
Key exclusion criteria (9 listed)
- Presence or history of drug hypersensitivity or allergic disease
- History or presence of dermatological disorders
- Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
- Prior opportunistic infections within 6 months before inclusion
- History or presence of listeriosis or tuberculosis
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) DP1Pharmaceutical form:solution Route of administration: subcutaneous | Biological | SAR231893 (REGN668) Drug Product (DP) 1 |
| SAR231893 (REGN668) DP2Pharmaceutical form:solution Route of administration: subcutaneous | Biological | SAR231893 (REGN668) Drug Product (DP) 2 |
Primary outcome
Assessment of serum concentrations of SAR231893 (REGN668)
Time frame: Up to 57 Days
4 secondary outcomes
Pain evaluation at injection site using Visual Analog Scale (VAS)
Time frame: Up to 8 Days
Erythema at injection site by measuring diameter
Time frame: Up to 8 Days
Edema at injection site by measuring diameter
Time frame: Up to 8 Days
Number of participants experiencing adverse events
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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) DP1 and SAR231893 (REGN668) DP2 in people with Healthy, 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 9 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 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?
Assessment of serum concentrations of SAR231893 (REGN668) (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 NCT01537640, 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.