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Completed

NCT Number: NCT05624294

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

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.

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Key information

Conditions

Primary Biliary Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CS0159

Drug

Tablets administered orally

Placebo

Drug

Tablets administered orally

Primary outcomes

  1. Incidence and severity of adverse events [Safety and Tolerability]

    Time frame: Upto day 15

    Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.

  2. Dose PK Parameter(C-max)

    Time frame: day 1, day 7

    Evaluate the Peak Plasma Concentration.

  3. Dose PK Parameter(AUC)

    Time frame: day 1, day 7

    Evaluate the Area under the plasma concentration versus time curve.

Secondary outcomes

  1. Food effect PK Parameter(C-max)

    Time frame: day 10

    Evaluate the Peak Plasma Concentration.

  2. Food effect PK Parameter(AUC)

    Time frame: day 10

    Evaluate the Area under the plasma concentration versus time curve.

  3. QTc analysis

    Time frame: day 1, day 7

    analysize the plasma Concentration relevance to QTcF

Sponsors and collaborators

Lead sponsor

Cascade Pharmaceuticals, Inc

Other

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2022
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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