Primary Sclerosing Cholangitis (PSC)
Conditions
Brief 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.
Interventions
DRUGCS0159
Tablets administered orally
Sponsors
Covance
Cascade Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the safety and tolerability of multiple doses of CS0159 | up to Day 44 | Incidence and severity of adverse events |
| Multiple-Dose PK Parameter: (AUCtau) | Day 1 after dosing; day 14 | AUC over one dosing interval |
| To characterize the safety and tolerability of single dose of CS0159 | up to Day 31 | Incidence and severity of adverse events |
| Single-Dose Pharmacokinetic (PK) Parameter | Day 1 after dosing | Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞) |
| Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last) | Day 1 after dosing | AUC from time zero to the time of the last measured concentration |
| Single-Dose Pharmacokinetic (PK) Parameter: (Cmax) | Day 1 after dosing | Maximum observed plasma concentration |
| Single-Dose Pharmacokinetic (PK) Parameter: (Tmax) | Day 1 after dosing | Time of the maximum observed plasma concentration |
| Multiple-Dose PK Parameter | Day 1 after dosing; day 14 | Maximum concentration during a dosing interval Ct\_max |
| Multiple-Dose PK Parameter: (Ct_min, Day 14) | Day 1 after dosing; day 14 | Minimum concentration during a dosing interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic (PD) Parameter: C4 | Day -1; day 1 | serum concentration |
| Pharmacodynamic (PD) Parameter: FGF19 | Day -1; day 1 | fibroblast growth factor 19 |
Countries
United States
Outcome results
None listed