Rheumatoid ArthritisPhase 1NCT06159452
Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects
A Phase 1 study testing SAR153191-P3 drug product, SAR153191-P2 drug product and SAR153191-C1F3 drug product in people with Rheumatoid Arthritis, run by Sanofi.
Trial summary
Primary objective: To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SAR153191-P3 drug product, SAR153191-P2 drug product and SAR153191-C1F3 drug product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 9 Jul 2010to 21 Dec 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
About this study
Official title: Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses, in Healthy Male Subjects
Primary objective:
To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.
Secondary objectives:
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.
To assess the safety of the different SAR153191 drug products administered subcutaneously.
Read the detailed description
Up to 35 Days
- Conditions
- Rheumatoid Arthritis
- Being tested
- SAR153191-P3 drug product, SAR153191-P2 drug product, SAR153191-C1F3 drug product
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR153191-P3 drug productDrug
Also called SAR153191
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
SAR153191-P2 drug productDrug
Also called SAR153191
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
SAR153191-C1F3 drug productDrug
Also called SAR153191
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | SAR153191 - P3 drug product concentration 1 dose 1 Receives: Drug: SAR153191-P3 drug product |
| Group B | Experimental | SAR153191 - P2 drug product concentration 2 dose 2 Receives: Drug: SAR153191-P2 drug product |
| Group C | Experimental | SAR153191 - P3 drug product concentration 2 dose 2 Receives: Drug: SAR153191-P3 drug product |
| Group D | Experimental | SAR153191 - P3 drug product concentration 3 dose 3 Receives: Drug: SAR153191-P3 drug product |
| Group B' | Experimental | SAR153191 - P2 drug product concentration 2 dose 3 Receives: Drug: SAR153191-P2 drug product |
| Group C' | Experimental | SAR153191 - P3 drug product concentration 2 dose 3 Receives: Drug: SAR153191-P3 drug product |
| Group E' | Active comparator | SAR153191 - CIF3 drug product concentration 2 dose 3 Receives: Drug: SAR153191-C1F3 drug product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting injection site reactions
Injection site reactions include pain, erythema an edema.
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration
Secondary outcomes (7)
Pharmacokinetics: Cmax
Maximum plasma concentration observed
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: tmax
First time to reach Cmax
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUClast
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUC
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: t1/2z
Terminal half-life associated with the terminal slope (λz)
Measured: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
Measured: Up to 35 Days
Incidence of anti-SAR153191 antibodies
Measured: At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start9 Jul 2010
- Primary completion21 Dec 2010
- Study completion21 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159452
- Sponsor's protocol ID
- TDU11373
- Other IDs
- U1111-1293-6227
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06159452
- Acronym / sponsor ID
- TDU11373
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2010 (actual)
- Primary completion
- 21 Dec 2010 (actual)
- Study completion
- 21 Dec 2010 (actual)
- First posted
- 6 Dec 2023 (actual)
- 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 the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.
Secondary objectives:
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.
To assess the safety of the different SAR153191 drug products administered subcutaneously.
Detailed description
Up to 35 Days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SAR153191-P3 drug productSAR153191 - P3 drug product concentration 1 dose 1 |
| Group B | Experimental | Drug: SAR153191-P2 drug productSAR153191 - P2 drug product concentration 2 dose 2 |
| Group C | Experimental | Drug: SAR153191-P3 drug productSAR153191 - P3 drug product concentration 2 dose 2 |
| Group D | Experimental | Drug: SAR153191-P3 drug productSAR153191 - P3 drug product concentration 3 dose 3 |
| Group B' | Experimental | Drug: SAR153191-P2 drug productSAR153191 - P2 drug product concentration 2 dose 3 |
| Group C' | Experimental | Drug: SAR153191-P3 drug productSAR153191 - P3 drug product concentration 2 dose 3 |
| Group E' | Active comparator | Drug: SAR153191-C1F3 drug productSAR153191 - CIF3 drug product concentration 2 dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SAR153191-P3 drug productAlso: SAR153191Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection | Drug | Group A, Group C, Group C', Group D |
| SAR153191-P2 drug productAlso: SAR153191Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection | Drug | Group B, Group B' |
| SAR153191-C1F3 drug productAlso: SAR153191Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection | Drug | Group E' |
Primary outcome
Number of participants reporting injection site reactions
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration
Injection site reactions include pain, erythema an edema.
7 secondary outcomes
Pharmacokinetics: Cmax
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: tmax
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUClast
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: AUC
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Pharmacokinetics: t1/2z
Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration
Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
Time frame: Up to 35 Days
Incidence of anti-SAR153191 antibodies
Time frame: At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive)
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 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR153191-P3 drug product, SAR153191-P2 drug product and SAR153191-C1F3 drug product in people with Rheumatoid Arthritis, run by Sanofi.
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 0 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 2023. Status can change between updates, so confirm with the study contact before making plans.
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 reporting injection site reactions (time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration). 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 6 Dec 2023.