Active — Not RecruitingPhase 1

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

China80 participantsStarted 2025-04-22

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Safety and tolerability

Timeframe: Day1 to Day 28

NCT IDNCT06485245

SponsorCascade Pharmaceuticals, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-20