At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 79 enrolled
Drug / intervention
CS0159drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating CS0159 for Primary Sclerosing Cholangitis (PSC). Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis (PSC)
CountriesUnited States
CollaboratorsCovance
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionSep 2022
Study CompletionOct 2022
TodayJul 2026
First PostedOct 19, 2021
Enrollment StartOct 26, 2021
Primary CompletionSep 16, 2022
Study CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.7 years ago
Interventions
CS0159drug
Tablets administered orally