Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159

Completed · Phase 1 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis (PSC)

In brief

The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part also involves a pilot food effect (FE) study, designed to assess the food effect on single-dose PK profile in healthy subjects.

Key facts

Study ID

NCT05082779

Run by

Cascade Pharmaceuticals, Inc

People needed

79

Starts

2021-10-26

Expected to finish

2022-10-12

Last updated by the study team

2022-10-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and non-pregnant female volunteers
• In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations

You may not qualify if…

• 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.

Where it is running

• Labcorp Clinical Research Unit, Inc. — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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