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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1217-2909 | Registry Identifier | ICTRP |
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Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR441344 | Experimental | Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously |
|
| placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR441344 | Drug | Solution for intravenous/subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with adverse event(AE) | Number of participants with AE from baseline to day 127 | From baseline to day 127 |
| Part 2: Number of participants with adverse event (AE) | Number of participants with AE from baseline to day 155 | From baseline to day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter: Cmax | Maximum plasma concentration (Cmax) observed | From Day 1 to Day 127 and to Day 155 |
| Assessment of PK parameter: tmax | First time to reach Cmax (tmax) |
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Inclusion criteria
- Having given written informed consent prior to undertaking any study-related procedure.
Exclusion criteria
- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD-Site Number:8400001 | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| TDU15525 Plain Language Results Summary | View source |
| TDR15526 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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| placebo |
| Drug |
Solution for intravenous/subcutaneous injection |
|
| Keyhole limpet hemocyanin | Biological | Subcutaneous Lyophilized powder for reconstitution |
|
| From Day 1 to Day 127 and Day 155 |
| Assessment of PK parameter: AUClast | Area under the plasma concentration versus time curve from time zero to the real time | From Day 1 to Day 127 |
| Assessment of PK parameter: AUC | From Day 1 to Day 127 | Area under the plasma concentration versus time curve extrapolated to infinity |
| Assessment of PK parameter: AUC0-tau | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours) | From day 1 to Day 155 |
| Assessment of PK parameter: Ctrough | Plasma concentration observed just before treatment administration during repeated dosing | From Day 1 to Day 155 |
| Assessment of PK parameter: t1/2z | Terminal half-life associated with the terminal slope (λz) | From Day 1 to Day 127 and Day 155 |
| Assessment of PK parameter: CL(/F) | From Day 1 to Day 127 | Apparent total body clearance of a drug from the plasma |
| Assessment of PK parameter: CLss(/F) | From day 1 to Day 155 | Apparent total body clearance of a drug from the plasma |
| Anti-SAR441344 antibodies | Number of subjects with treatment emergent anti-drug antibody formation | From Day 1 to Day 127 and Day 155 |
| Assessment of anti-KLH IgG and IgM | Measurement of anti-KLH IgG and IgM levels in response to KLH immunization | From Day 1 to Day 127 and Day 155 |
| AE attributed to KLH immunization | Number of participants with AE attributed to KLH immunization | From Day 1 to Day 127 and Day 155 |
| ID | Term |
|---|---|
| C032808 | keyhole-limpet hemocyanin |
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