protocolSection identificationModule nctId: NCT06326814, orgStudyIdInfo id: TDU16837, secondaryIdInfos id: U1111-1298-7281, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-11, primaryCompletionDateStruct date: 2023-05-05, completionDateStruct date: 2023-05-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: Primary objective* The tolerability and safety of SAR443809 Secondary* The PK parameters of SAR443809* The PD activity of SAR443809* The immunogenicity of SAR443809, conditionsModule conditions: Paroxysmal Nocturnal Hemoglobinuria, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Humanized anti-Factor Bb monoclonal antibody, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Incidence of potentially Clinical laboratory abnormalities, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: absolute bioavailability (F), secondaryOutcomes measure: Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]), secondaryOutcomes measure: Complement classical pathway activity (Wieslab CP), secondaryOutcomes measure: Incidence of treatment -emergent Anti-SAR443809 antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Parexel International Site Number : 8400002, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, locations facility: Parexel International Site Number : 8400003, city: Baltimore, state: Maryland, zip: 21255, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False