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

NCT ID: NCT05082779

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2022-10-12

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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A1: 0.2 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort A2: 0.6 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort A3: 1 mg

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 Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort A4: 2 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort A5: 4 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort A6: 8 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort B1: 0.4 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort B2: 1 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort B3: 2 mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Cohort B4: 4mg

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

Group Type: EXPERIMENTAL

CS0159

Intervention Type: DRUG

Tablets administered orally

Interventions

CS0159

Tablets administered orally

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

1. Healthy male and non-pregnant female volunteers

2. 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

1. Subjects with special dietary requirements and cannot follow a uniform diet.

2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.

3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Cascade Pharmaceuticals, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Doisy, MD

Role: PRINCIPAL_INVESTIGATOR

Labcorp Clinical Research Unit, Inc.

Locations

Labcorp Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

CS0159-001

Identifier Type: -

Identifier Source: org_study_id