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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1318-3393 | Registry Identifier | ICTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). |
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| Group 2 | Experimental | Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). |
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| Group 3 | Active Comparator | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. |
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| Group 4 | Experimental | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR445229 | Combination Product | Single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Cmax | Maximum serum concentration observed. | 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. | 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. | From Day 1 up to End of study (approximately 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Tmax | Time to reach Cmax. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami- Site Number : 8400001 | Miami | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| BEQ19340 Plain Language Results Summary | View source |
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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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Participants will be randomized in a 1:1:1:1 ratio.
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This study is open-label. Participants, investigators, and study members have access to treatment assignment.
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| 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. | From Day 1 up to End of study (approximately 24 weeks) |
| PK parameter: Vz/F | Apparent volume of distribution during the terminal (λz) phase. | From Day 1 up to End of study (approximately 24 weeks) |
| Pharmacokinetic (PK) profile: AUCext | Percentage of extrapolated part of AUC. | 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). | 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). | 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. | Day 1 |
| Incidence of participants with ADA (antidrug antibody) against amlitelimab. | Up to end of study (approximately 24 weeks) |