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

Cascade Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Primary Sclerosing Cholangitis (PSC)

Treatments: Drug: CS0159

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05082779

CS0159-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 10 patient groups

Cohort A1: 0.2 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort A2: 0.6 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort A3: 1 mg

Experimental group

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.

Treatment:

Drug: CS0159

Cohort A4: 2 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort A5: 4 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort A6: 8 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort B1: 0.4 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort B2: 1 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort B3: 2 mg

Experimental group

Description:

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

Treatment:

Drug: CS0159

Cohort B4: 4mg

Experimental group

Description:

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

Treatment:

Drug: CS0159