Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060380 in Healthy and Elevated LDL-C Subjects
NCT Number: NCT06573528
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: MASH
Interventions: DRUG: CS060380
Sponsor: Cascade Pharmaceuticals, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-06-10
Locations: Shanghai Xuhui Central Hospital, Shanghai, China

Summary:
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060380 in Healthy and Elevated LDL-C Subjects.

Primary Outcome Measures: AE, occurrence rate of AEs, Day1 to Day 28
Secondary Outcome Measures: Single-Dose Pharmacokinetic (PK) Parameter (AUC0-∞), AUC from time zero to infinity, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (AUC0-last), AUC from time zero to the last quantifiable concentration, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (Cmax), Maximum observed plasma concentration, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (Tmax), Time to the maximum observed plasma concentration, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (T1/2), Elimination half-life, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (CL/F), Apparent total plasma clearance, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (Kel), Elimination rate constant, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (MRT), Mean residence time, Day 1, day 2, day3, day4.|Single-Dose Pharmacokinetic (PK) Parameter (Vz/F), Apparent volume of distribution, Day 1, day 2, day3, day4.|Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_max), Maximum concentration during a dosing interval, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_min), Minimum concentration during a dosing interval, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (AUCtau), AUC over one dosing interval, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (Tmax), Tmax, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (T1/2), T1/2, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (CL/F), CL/F, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (DF), Degree of fluctuation, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_av), Mean plasma concentration during a dosing interval, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.|Multiple-Dose Pharmacokinetic (PK) Parameter (Rac), Accumulation factor, Day 1, day 2, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15.
Other Outcome Measures: Pharmacodynamic (PD) Characteristics (Fasting serum LDL-C), PD Characteristics of Multiple Oral Doses of CS060380 in Subjects with Elevated LDL-C, Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic(PD) Characteristics (HDL-C), High-density lipoprotein cholesterol., Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (TG), Triglyceride., Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (TC), Total cholesterol., Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (Apo B), Apolipoprotein B., Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (SHBG), Sex hormone binding globulin., Day 1, day 3, day 5, day 7, day 14, day 15, day 17.|Thyroid function indicators (Total serum T3), Total serum T3, Day 3, day 7, day 10 , day 15, day 17.|Thyroid function indicators (T3), Disassociate T3, Day 3, day 7, day 10 , day 15, day 17.|Thyroid function indicators (T4), Thyroxine T4., Day 3, day 7, day 10 , day 15, day 17.|Thyroid function indicators (disassociate T4), Disassociate T4., Day 3, day 7, day 10 , day 15, day 17.|Thyroid function indicators (TSH), Thyroid stimulating hormone., Day 3, day 7, day 10 , day 15, day 17.|Drug concentration (QTcF), Orrected QT interval by Fridericia formula., Day 1, day 2, day 3.