protocolSection identificationModule nctId: NCT06349473, orgStudyIdInfo id: SR604-1, briefTitle: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-27, completionDateStruct date: 2025-09-27, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Equilibra Bioscience LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with severe Hemophilia A or Hemophilia B, with or without inhibitors (Part B)., conditionsModule conditions: Healthy Participants, conditions: Hemophilia A, conditions: Hemophilia B, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: SR604, interventions name: Placebo, outcomesModule primaryOutcomes measure: Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers, secondaryOutcomes measure: Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t]), secondaryOutcomes measure: Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf]), secondaryOutcomes measure: Parts A and B: Maximum Concentration (Cmax) of SR604, secondaryOutcomes measure: Parts A and B: Time to Maximum Concentration (tmax) of SR604, secondaryOutcomes measure: Parts A and B: Terminal Half-life (T1/2) of SR604, secondaryOutcomes measure: Part A: Clearance Following Extravascular Administration (CL/F) of SR604, secondaryOutcomes measure: Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604, secondaryOutcomes measure: Parts B: Concentration before the next dose administration (Ctrough), secondaryOutcomes measure: Parts B: Area Under the Serum Concentration-time Curve within One Dosing Interval (AUCtau), secondaryOutcomes measure: Parts B: Accumulation Ratio (R) of SR604, secondaryOutcomes measure: Parts B: Number of Bleeding Events, secondaryOutcomes measure: Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints, secondaryOutcomes measure: Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: California Clinical Trials Medical Group (CCTMG), status: RECRUITING, city: Glendale, state: California, zip: 91206, country: United States, contacts name: Esther Yoon, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False