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CS0159 for Primary Sclerosing Cholangitis

Phase 1
Waitlist Available
Led By Kathleen Doisy, MD
Research Sponsored by Cascade Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 after dosing; day 14
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective. It is double-blinded, meaning that neither the participants nor the researchers know who is taking the real drug or the fake drug. It is also placebo-controlled, meaning that some participants will receive a fake drug with no active ingredient.

Eligible Conditions
  • Primary Sclerosing Cholangitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 after dosing; day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 after dosing; day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiple-Dose PK Parameter
Multiple-Dose PK Parameter: (AUCtau)
Multiple-Dose PK Parameter: (Ct_min, Day 14)
+6 more
Secondary outcome measures
Pharmacodynamic (PD) Parameter: C4
Pharmacodynamic (PD) Parameter: FGF19

Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort B4: 4mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.
Group II: Cohort B3: 2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.
Group III: Cohort B2: 1 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.
Group IV: Cohort B1: 0.4 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.
Group V: Cohort A6: 8 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.
Group VI: Cohort A5: 4 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.
Group VII: Cohort A4: 2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.
Group VIII: Cohort A3: 1 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 1 mg or placebo once on Day 1 followed by a 7-day washout period then given in 1 mg tablet (in fed state) on Day 8.
Group IX: Cohort A2: 0.6 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.
Group X: Cohort A1: 0.2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CS0159
2022
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cascade Pharmaceuticals, IncLead Sponsor
5 Previous Clinical Trials
266 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,737 Total Patients Enrolled
Kathleen Doisy, MDPrincipal InvestigatorLabcorp Clinical Research Unit, Inc.
1 Previous Clinical Trials
210 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159
2021. "Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082779.
~23 spots leftby Apr 2025
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