Clinical trial NCT05082779: Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Sclerosing Cholangitis (PSC)
Lead sponsor: Cascade Pharmaceuticals, Inc
Sponsor class: OTHER
Collaborators: name: Covance
First posted: 2021-10-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Single-Dose Pharmacokinetic (PK) Parameter
timeFrame: Day 1 after dosing
measure: Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)
timeFrame: Day 1 after dosing
measure: Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)
timeFrame: Day 1 after dosing
measure: Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)
timeFrame: Day 1 after dosing
measure: Multiple-Dose PK Parameter
timeFrame: Day 1 after dosing; day 14
measure: Multiple-Dose PK Parameter: (Ct_min, Day 14)
timeFrame: Day 1 after dosing; day 14
measure: Multiple-Dose PK Parameter: (AUCtau)
timeFrame: Day 1 after dosing; day 14
measure: To characterize the safety and tolerability of single dose of CS0159
timeFrame: up to Day 31
measure: To characterize the safety and tolerability of multiple doses of CS0159
timeFrame: up to Day 44
Secondary outcomes:
measure: Pharmacodynamic (PD) Parameter: FGF19
timeFrame: Day -1; day 1
measure: Pharmacodynamic (PD) Parameter: C4
timeFrame: Day -1; day 1
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Labcorp Clinical Research Unit, Inc.
state: Florida
Study officials:
affiliation: Labcorp Clinical Research Unit, Inc.
name: Kathleen Doisy, MD
role: PRINCIPAL_INVESTIGATOR
References: