protocolSection identificationModule nctId: NCT06260527, orgStudyIdInfo id: ARTS-011-101, briefTitle: Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Allorion Therapeutics Inc, class: INDUSTRY, descriptionModule briefSummary: This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers., conditionsModule conditions: Chinese Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Single ascending dose (SAD) following by multiple ascending dose (MAD) and food effect study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: ARTS-011, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs, primaryOutcomes measure: Number of Adverse Events (AEs) according to severity, primaryOutcomes measure: Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature), primaryOutcomes measure: Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval), primaryOutcomes measure: Number of participants with change from baseline physical examination, primaryOutcomes measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities, primaryOutcomes measure: Number of participants with change in 24-hour creatine clearance from baseline, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit, secondaryOutcomes measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD), secondaryOutcomes measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD), secondaryOutcomes measure: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of ARTS-011 in Single Ascending Dose (SAD), secondaryOutcomes measure: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of ARTS-011 in Multiple Ascending Dose (MAD), secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit, secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Ruihua Dong, MD, role: CONTACT, phone: 010-80839386, email: ruihua_dong_rw@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False