Healthy VolunteersPhase 1NCT07146750
A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
A Phase 1 study testing SAR445229 in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial summary
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SAR445229
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 8 Apr 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
- Certified as healthy by a comprehensive clinical assessment [detailed medical history and complete physical examination including neurological exam (at screening and D1), skin, and mucous membranes].
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- History of solid organ (including corneal transplant) or stem cell transplant.
- Any pre-planned major elective surgery known about at baseline visit that in the Investigator's opinion would impede participation in the study.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
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- Blood donation, any volume, within 2 months before inclusion.
- Any nicotine use within 4 weeks before study inclusion. Regular smoking more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking or using nicotine for duration of the study.
- If female, pregnancy (defined as positive beta human chorionic gonadotropin [β-HCG] blood test), breast feeding.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami- Site Number : 8400001
Miami, Florida, 33014
About this study
Official title: An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- SAR445229
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445229Combination product
Also called Amlitelimab
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). Receives: Combination Product: SAR445229 |
| Group 2 | Experimental | Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). Receives: Combination Product: SAR445229 |
| Group 3 | Active comparator | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. Receives: Combination Product: SAR445229 |
| Group 4 | Experimental | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. Receives: Combination Product: SAR445229 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter: Cmax
Maximum serum concentration observed.
Measured: From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC last
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Measured: From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC
Area under the serum concentration versus time curve extrapolated to infinity.
Measured: From Day 1 up to End of study (approximately 24 weeks)
Secondary outcomes (9)
PK parameter: Tmax
Time to reach Cmax.
Measured: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: t1/2z
Terminal half-life associated with the terminal slope (λz) determined
Measured: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: CL/F
Apparent total body clearance after a single subcutaneous administration of a drug from the serum.
Measured: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: Vz/F
Apparent volume of distribution during the terminal (λz) phase.
Measured: From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUCext
Percentage of extrapolated part of AUC.
Measured: From Day 1 up to End of study (approximately 24 weeks)
Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs
TEAEs (Treatment-Emergent Adverse Events) including ISRs (local tolerability assessment), TESAEs (Treatment-Emergent Serious Adverse Events), and/or TEAESIs (Treatment Emergent Adverse Event of Special Interest).
Measured: Up to end of study (approximately 24 weeks)
Percentage of participants with potentially clinically significant abnormalities
Clinically significant abnormalities including Clinical laboratory evaluations, Vital signs, electrocardiogram (ECG).
Measured: Up to end of study (approximately 24 weeks)
Visual analog scale score for pain with subcutaneous administration
VAS (visual analog scale) is used to evaluate pain at the treatment injection site. In a range between 0 to 10 where 10 is the worst pain.
Measured: Day 1
Incidence of participants with ADA (antidrug antibody) against amlitelimab.
Measured: Up to end of study (approximately 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start25 Aug 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Model description
- Participants will be randomized in a 1:1:1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146750
- Sponsor's protocol ID
- BEQ19340
- Other IDs
- U1111-1318-3393
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07146750
- Acronym / sponsor ID
- BEQ19340
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 28 Aug 2025 (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.
This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized in a 1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Combination Product: SAR445229Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). |
| Group 2 | Experimental | Combination Product: SAR445229Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). |
| Group 3 | Active comparator | Combination Product: SAR445229Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. |
| Group 4 | Experimental | Combination Product: SAR445229Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
- Certified as healthy by a comprehensive clinical assessment [detailed medical history and complete physical examination including neurological exam (at screening and D1), skin, and mucous membranes].
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
Key exclusion criteria (10 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- History of solid organ (including corneal transplant) or stem cell transplant.
- Any pre-planned major elective surgery known about at baseline visit that in the Investigator's opinion would impede participation in the study.
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 |
|---|---|---|
| SAR445229Also: AmlitelimabSingle dose | Combination product | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
PK parameter: Cmax
Time frame: From Day 1 up to End of study (approximately 24 weeks)
Maximum serum concentration observed.
Pharmacokinetic (PK) profile: AUC last
Time frame: From Day 1 up to End of study (approximately 24 weeks)
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Pharmacokinetic (PK) profile: AUC
Time frame: From Day 1 up to End of study (approximately 24 weeks)
Area under the serum concentration versus time curve extrapolated to infinity.
9 secondary outcomes
PK parameter: Tmax
Time frame: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: t1/2z
Time frame: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: CL/F
Time frame: From Day 1 up to End of study (approximately 24 weeks)
PK parameter: Vz/F
Time frame: From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUCext
Time frame: From Day 1 up to End of study (approximately 24 weeks)
Percentage of participants who experienced TEAEs including ISRs, TESAEs, and/or TEAESIs
Time frame: Up to end of study (approximately 24 weeks)
Percentage of participants with potentially clinically significant abnormalities
Time frame: Up to end of study (approximately 24 weeks)
Visual analog scale score for pain with subcutaneous administration
Time frame: Day 1
Incidence of participants with ADA (antidrug antibody) against amlitelimab.
Time frame: Up to end of study (approximately 24 weeks)
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 20 Apr 2026.
- BEQ19340 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Screening Protocol
Pain
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.
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 SAR445229 in people with Healthy Volunteers, 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 3 inclusion and 10 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 20 Apr 2026. 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?
PK parameter: Cmax (time frame: From Day 1 up to End of study (approximately 24 weeks)). The study lists 3 primary outcomes in all. 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 20 Apr 2026.