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Recruiting NCT05624294

Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects

Conditions: Primary Biliary Cholangitis

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 36
Sponsor: Cascade Pharmaceuticals, Inc

Location: China

Summary

This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.

Eligibility Criteria

Inclusion Criteria:Healthy adult subjects of 18 years to 55 years.Weight: Male≥50kg, female≥45kg BMI: 18~32kg/m².In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation.Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.Exclusion Criteria:Subjects with special dietary requirements and cannot follow a uniform diet.Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05624294). StuddyBuddy aggregates publicly available trial information.