nctId: NCT06260527 id: ARTS-011-101 briefTitle: Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers overallStatus: RECRUITING date: 2023-08-30 date: 2024-05-30 date: 2024-09-30 date: 2024-02-15 date: 2024-02-15 name: Allorion Therapeutics Inc class: INDUSTRY 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. conditions: Chinese Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single ascending dose (SAD) following by multiple ascending dose (MAD) and food effect study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: ARTS-011 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs measure: Number of Adverse Events (AEs) according to severity measure: Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature) measure: Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) measure: Number of participants with change from baseline physical examination measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities measure: Number of participants with change in 24-hour creatine clearance from baseline measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) 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) measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD) measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD) 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) 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) measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort 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 measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort measure: Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Ruihua Dong, MD role: CONTACT phone: 010-80839386 email: ruihua_dong_rw@163.com lat: 39.9075 lon: 116.39723 hasResults: False