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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

No Placebo-Only Group

Summary

This trial tests a new drug called CS0159 in healthy people to see if it is safe and how it behaves in their bodies. Researchers will study how the drug is absorbed, distributed, metabolized, and excreted, as well as its effects on the body.

Eligible Conditions

Primary Sclerosing Cholangitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 after dosing; day 14

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multiple-Dose PK Parameter

Multiple-Dose PK Parameter: (AUCtau)

Multiple-Dose PK Parameter: (Ct_min, Day 14)

+6 more

Secondary study objectives

Pharmacodynamic (PD) Parameter: C4

Pharmacodynamic (PD) Parameter: FGF19

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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