protocolSection identificationModule nctId: NCT06360640, orgStudyIdInfo id: APC148-001, secondaryIdInfos id: 2023-507939-38-00, type: OTHER, domain: EU Trial no, briefTitle: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AdjuTec Pharma AS, class: INDUSTRY, collaborators name: CTC Clinical Trial Consultants AB, descriptionModule briefSummary: The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Placebo-controlled, 6 sequential cohorts., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: This is a double-blind trial., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: APC148 and Placebo, outcomesModule primaryOutcomes measure: Incidence and intensity of adverse events (AEs), primaryOutcomes measure: Incidence and intensity of serious adverse events (SAEs), primaryOutcomes measure: Incidence and intensity of infusion-related AEs, primaryOutcomes measure: Time course of local tolerability reactions, primaryOutcomes measure: Changes from baseline in blood pressure, primaryOutcomes measure: Changes from baseline in respiratory rate, primaryOutcomes measure: Changes from baseline in body temperature, primaryOutcomes measure: Changes from baseline in heart rate, primaryOutcomes measure: Changes from baseline in PQ/PR interval, primaryOutcomes measure: Changes from baseline in QRS interval, primaryOutcomes measure: Changes from baseline in QT interval, primaryOutcomes measure: Changes from baseline in QTcF interval, primaryOutcomes measure: Changes from baseline in Clinical Laboratory Profile, primaryOutcomes measure: Changes from baseline in physical examination, secondaryOutcomes measure: APC148 plasma concentrations, secondaryOutcomes measure: APC148 urine concentrations, secondaryOutcomes measure: Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24, secondaryOutcomes measure: PK parameter in plasma - AUC0-inf, secondaryOutcomes measure: PK parameter in plasma - AUC0-last, secondaryOutcomes measure: PK parameter in plasma - Cmax, secondaryOutcomes measure: PK parameter in plasma - Tmax, secondaryOutcomes measure: PK parameter in plasma - T1/2, secondaryOutcomes measure: PK parameter in plasma - Clearance (CL), secondaryOutcomes measure: PK parameter in plasma - Vz, secondaryOutcomes measure: PK parameter in plasma - Vss determination of plasma concentrations will be collected., secondaryOutcomes measure: PK parameters in urine - A(e), secondaryOutcomes measure: PK parameters in urine - fe, secondaryOutcomes measure: PK parameter in urine - renal clearance (CLr), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Consultants AB, city: Uppsala, country: Sweden, contacts name: Erik Rein-Hedin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False