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

NCT06485245 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CS060304-FIH-CN-I-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MASH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Single-Dose Pharmacokinetic (PK) Parameter (AUC0-∞)

  Day 1

• Single-Dose Pharmacokinetic (PK) Parameter (AUC0-last)

  Day 1

• Single-Dose Pharmacokinetic (PK) Parameter (Cmax)

  Day 1

• Single-Dose Pharmacokinetic (PK) Parameter (Tmax)

  Day 1

• Single-Dose Pharmacokinetic (PK) Parameter (T1/2)

  Day 1

Other Outcomes (12)

• Pharmacodynamic (PD) Characteristics (Fasting serum LDL-C)

  Day 1, day3, day 5, day 7, day 14, day 15, day 17.

• Pharmacodynamic (PD) Characteristics (HDL-C)

  Day 1, day3, day 5, day 7, day 14, day 15, day 17.

• Pharmacodynamic (PD) Characteristics (TG)

  Day 1, day 3, day 7, day 10, day 14, day 15, day 17.

Study Arms (10)

Cohort A1: 0.2mg CS060304

EXPERIMENTAL

Healthy subjects in a fasting state will receive a single dose of CS060304 0.2 mg or placebo.

Drug: CS060304

Cohort A2: 1mg CS060304

EXPERIMENTAL

Healthy subjects in a fasting state will receive a single dose of CS060304 1 mg or placebo.

Drug: CS060304

Cohort A3: 4mg CS060304

EXPERIMENTAL

Healthy subject in fasted state receive a single oral dose of CS060304 4 mg or placebo on day 1, followed by a 4 day washout period, subjects in fed state will receive the same single oral dose of CS060304 4mg or placebo on day 5.

Drug: CS060304

Cohort A4: 10mg CS060304

EXPERIMENTAL

Healthy subjects in a fasting state will receive a single dose of CS060304 10 mg or placebo.

Drug: CS060304

Cohort A5: 20mg CS060304

EXPERIMENTAL

Healthy subjects in a fasting state will receive a single dose of CS060304 20 mg or placebo.

Drug: CS060304

Cohort A6: 40mg CS060304

EXPERIMENTAL

Healthy subjects in a fasting state will receive a single dose of CS060304 40 mg or placebo.

Drug: CS060304

Cohort B1: 2mg CS060304

EXPERIMENTAL

Elevated LDL-C subjects will receive the CS060304 2 mg or placebo once daily for a consecutive 14 days.

Drug: CS060304

Cohort B2: 5mg CS060304

EXPERIMENTAL

Elevated LDL-C subjects will receive the CS060304 5 mg or placebo once daily for a consecutive 14 days.

Drug: CS060304

Cohort B3: 10mg CS060304

EXPERIMENTAL

Elevated LDL-C subjects will receive the CS060304 10 mg or placebo once daily for a consecutive 14 days.

Drug: CS060304

Cohort B4: 20mg CS060304

EXPERIMENTAL

Elevated LDL-C subjects will receive the CS060304 20 mg or placebo once daily for a consecutive 14 days.

Drug: CS060304

Interventions

CS060304 DRUG

Tablets administered orally

Also known as: Pleacbo

Cohort A1: 0.2mg CS060304; Cohort A2: 1mg CS060304; Cohort A3: 4mg CS060304; Cohort A4: 10mg CS060304; Cohort A5: 20mg CS060304; Cohort A6: 40mg CS060304; Cohort B1: 2mg CS060304; Cohort B2: 5mg CS060304; Cohort B3: 10mg CS060304; Cohort B4: 20mg CS060304

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SAD
• Sign and date the ICF.
• Signing ICF age≥18 years≤55 years, male or female.
• Weight: Male≥50kg, female≥45kg BMI: 18\~28kg/m².
• Female or male subjects must be eligible for contraception during the study and for three months after the last dose.
• Normal renal function.
• Good general health.
• No significant medical history, in good general health as assessed by the study during the Screening Period and no more than 28 days from the first dose.
• Understand and comply with study procedures and limitations.
• MAD
• Sign and date the ICF.
• Signing ICF age≥18 years≤65 years, male or female.
• Weight: Male≥50kg, female≥45kg BMI: 18\~35kg/m².
• Screening period, fasting LDL-C \> 110 mg/dL (2.85 mmol/L).
• Female or male subjects must be eligible for contraception during the study and for three months after the last dose.

You may not qualify if:

• SAD
• Special dietary requirements, not following a uniform diet.
• Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
• History of febrile illness or active infection within 7 days prior to first dose.
• Positive urine drug screens at screening or baseline.
• History of substance/drug abuse in the 5 years prior to the start of the trial, or a positive screening or baseline drug screen result.
• History of previous corrected QT interval (QTc) prolongation:
• Screening periods QTcF ≥ 450 ms.
• Family history of hypocalcaemia or long QT interval syndrome.
• Use of drugs causing QT/QTc prolongation.
• Investigator judgement of clinically significant abnormal ECG results.
• Abnormal liver function: AST, ALT, ALP, GGT and TBIL\>ULN.
• Smoking or use of nicotine products within 3 months prior to screening and during the study period.
• Use of other investigational drugs 40 days prior to enrolment or within at least 5 half-lives of drug use.
• Positive screening results for infectious diseases during the screening period, include HIV, HBsAg, HBcAb, HCV antibody tests.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

• Zhang Shuyang

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: April 22, 2025
• Primary Completion: November 20, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)