Primary Sclerosing Cholangitis (PSC) Clinical Trial
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06037577 -
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT01672853 -
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
|
Phase 2 | |
| Completed |
NCT02061540 -
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
|
Phase 2 | |
| Completed |
NCT01819766 -
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
|
N/A | |
| Active, not recruiting |
NCT01161992 -
Genomics of Primary Sclerosing Cholangitis (PSC)
|
||
| Completed |
NCT02808312 -
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
|
Phase 1 | |
| Completed |
NCT03333928 -
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
|
Phase 2 | |
| Completed |
NCT02177136 -
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
|
Phase 2 | |
| Completed |
NCT03766035 -
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
|
||
| Completed |
NCT01695174 -
A Pilot Study of Xifaxan to Treat Patients With PSC
|
Phase 1 | |
| Recruiting |
NCT06026865 -
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
|
N/A |