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

NCT05082779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

DRUG

CS0159

Tablets administered orally

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Cascade Pharmaceuticals, Inc

    lead OTHER

Principal Investigators

  • Kathleen Doisy, MD · Labcorp Clinical Research Unit, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2022-09-16
Completion
2022-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082779 on ClinicalTrials.gov