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

Primary Purpose

Primary Sclerosing Cholangitis (PSC)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CS0159

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis (PSC)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

Labcorp Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Cohort A1: 0.2 mg

Cohort A2: 0.6 mg

Cohort A3: 1 mg

Cohort A4: 2 mg

Cohort A5: 4 mg

Cohort A6: 8 mg

Cohort B1: 0.4 mg

Cohort B2: 1 mg

Cohort B3: 2 mg

Cohort B4: 4mg

Arm Description

Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.

Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.

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.

Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.

Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.

Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.

Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.

Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.

Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.

Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.

Outcomes

Primary Outcome Measures

Single-Dose Pharmacokinetic (PK) Parameter

Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞)

Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)

AUC from time zero to the time of the last measured concentration

Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)

Maximum observed plasma concentration

Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)

Time of the maximum observed plasma concentration

Multiple-Dose PK Parameter

Maximum concentration during a dosing interval Ct_max

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

Minimum concentration during a dosing interval

Multiple-Dose PK Parameter: (AUCtau)

AUC over one dosing interval

To characterize the safety and tolerability of single dose of CS0159

Incidence and severity of adverse events

To characterize the safety and tolerability of multiple doses of CS0159

Incidence and severity of adverse events

Secondary Outcome Measures

Pharmacodynamic (PD) Parameter: FGF19

fibroblast growth factor 19

Pharmacodynamic (PD) Parameter: C4

serum concentration

Full Information

NCT ID

NCT05082779

First Posted

September 25, 2021

Last Updated

October 15, 2022

Sponsor

Cascade Pharmaceuticals, Inc

Collaborators

Covance

1. Study Identification

Unique Protocol Identification Number

NCT05082779

Brief Title

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

Official Title

A Phase I, Randomized, Double-Blind, Placebo-Contralled, Single Asending Dose / Multiple Ascending Dose Study of CS0159 to to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Effect Food in Healthy Subject

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 26, 2021 (Actual)

Primary Completion Date

September 16, 2022 (Actual)

Study Completion Date

October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cascade Pharmaceuticals, Inc

Collaborators

Covance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

A total of 48 healthy subjects will be allocated to 1 of 6 cohorts (cohort A1~A6) in the SAD study, each cohort including 8 subjects (6 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single oral dose of CS0159 or placebo.To ensure the safety for all SAD cohorts (including A3 in both treatment periods). The MAD study will enroll 32 healthy subjects, allocated to 1 of 4 cohorts (cohort B1~B4) and each cohort including 8 participants (6 subjects will receive IND products and 2 receive placebo). Subjects will be randomly assigned to orally receive the IND product or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis (PSC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A1: 0.2 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.

Arm Title

Cohort A2: 0.6 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.

Arm Title

Cohort A3: 1 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Cohort A4: 2 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.

Arm Title

Cohort A5: 4 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.

Arm Title

Cohort A6: 8 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.

Arm Title

Cohort B1: 0.4 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.

Arm Title

Cohort B2: 1 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.

Arm Title

Cohort B3: 2 mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.

Arm Title

Cohort B4: 4mg

Arm Type

Experimental

Arm Description

Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.

Intervention Type

Drug

Intervention Name(s)

CS0159

Other Intervention Name(s)

Placebo

Intervention Description

Tablets administered orally

Primary Outcome Measure Information:

Title

Single-Dose Pharmacokinetic (PK) Parameter

Description

Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞)

Time Frame

Day 1 after dosing

Title

Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)

Description

AUC from time zero to the time of the last measured concentration

Time Frame

Day 1 after dosing

Title

Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)

Description

Maximum observed plasma concentration

Time Frame

Day 1 after dosing

Title

Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)

Description

Time of the maximum observed plasma concentration

Time Frame

Day 1 after dosing

Title

Multiple-Dose PK Parameter

Description

Maximum concentration during a dosing interval Ct_max

Time Frame

Day 1 after dosing; day 14

Title

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

Description

Minimum concentration during a dosing interval

Time Frame

Day 1 after dosing; day 14

Title

Multiple-Dose PK Parameter: (AUCtau)

Description

AUC over one dosing interval

Time Frame

Day 1 after dosing; day 14

Title

To characterize the safety and tolerability of single dose of CS0159

Description

Incidence and severity of adverse events

Time Frame

up to Day 31

Title

To characterize the safety and tolerability of multiple doses of CS0159

Description

Incidence and severity of adverse events

Time Frame

up to Day 44

Secondary Outcome Measure Information:

Title

Pharmacodynamic (PD) Parameter: FGF19

Description

fibroblast growth factor 19

Time Frame

Day -1; day 1

Title

Pharmacodynamic (PD) Parameter: C4

Description

serum concentration

Time Frame

Day -1; day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Doisy, MD

Organizational Affiliation

Labcorp Clinical Research Unit, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Labcorp Clinical Research Unit, Inc.

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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