Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects
NCT Number: NCT06485245
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: MASH
Interventions: DRUG: CS060304
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: 2024-08-14
Completion Date: 2025-09-30
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects.

Primary Outcome Measures: Safety and tolerability, Physical examination, vital signs, including blood pressure, pulse, respiratory rate, and body temperature, 12 lead electrocardiogram, electrocardiogram monitoring, laboratory tests (including blood biochemistry, blood routine, urine routine, coagulation function)., Day1 to Day 28
Secondary Outcome Measures: Single-Dose Pharmacokinetic (PK) Parameter (AUC0-∞), Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (AUC0-last), AUC from time zero (pre-dose) to the time of the last measured concentration., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (Cmax), Maximum observed plasma concentration., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (Tmax), Time to the maximum plasma concentration., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (T1/2), Elimination half-life., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (CL/F), Apparent total plasma clearance., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (Kel), Elimination rate constant., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (MRT), Mean residence time., Day 1|Single-Dose Pharmacokinetic (PK) Parameter (Vz/F), Apparent volume of distribution., Day 1|Multiple-Dose Pharmacokinetic (PK) Parameter (Ct_max), Maximum concentration during a dosing interva., 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), Time to the maximum plasma concentration., 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), Elimination half-life., 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), Apparent total plasma clearance., 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 CS060304 in Subjects with Elevated LDL-C, Day 1, day3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (HDL-C), High-density lipoprotein cholesterol., Day 1, day3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (TG), Triglyceride., Day 1, day 3, day 7, day 10, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (TC), Total cholesterol., Day 1, day3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (Apo B), Apolipoprotein B., Day 1, day3, day 5, day 7, day 14, day 15, day 17.|Pharmacodynamic (PD) Characteristics (SHBG), Sex hormone binding globulin., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Thyroid function indicators (total serum T3), Total serum T3., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Thyroid function indicators (T3), Disassociate T3., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Thyroid function indicators (T4), Thyroxine T4., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Thyroid function indicators (disassociate T4), Disassociate T4., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Thyroid function indicators (TSH), Thyroid stimulating hormone., Day 1, day3, day 7, day 10, day 14, day 15, day 17.|Drug concentration (QTcF), Orrected QT interval by Fridericia formula., Day 1, day 2.