NCT05082779

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
DRUG	CS0159	Tablets administered orally

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-09-16
• Completion: 2022-10-12
• First posted: 2021-10-19
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study