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

Cascade Pharmaceuticals, Inc79 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Sclerosing Cholangitis (PSC)

Interventions

CS0159DRUG

Tablets administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Labcorp Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Single-Dose Pharmacokinetic (PK) Parameter

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

Time frame: Day 1 after dosing

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

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

Time frame: Day 1 after dosing

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

Maximum observed plasma concentration

Time frame: Day 1 after dosing

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

Time of the maximum observed plasma concentration

Time frame: Day 1 after dosing

Multiple-Dose PK Parameter

Maximum concentration during a dosing interval Ct\_max

Time frame: Day 1 after dosing; day 14

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

Minimum concentration during a dosing interval

Time frame: Day 1 after dosing; day 14

Multiple-Dose PK Parameter: (AUCtau)

AUC over one dosing interval

Time frame: Day 1 after dosing; day 14

To characterize the safety and tolerability of single dose of CS0159

Incidence and severity of adverse events

Time frame: up to Day 31

To characterize the safety and tolerability of multiple doses of CS0159

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes