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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082779
• Other study ID #: CS0159-001
• Status: Completed
• Phase: Phase 1
• Start date: October 26, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: October 2021
• Source: Cascade Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 12, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis (PSC)

Intervention

Drug:
• CS0159
Tablets administered orally

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit, Inc.	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cascade Pharmaceuticals, Inc	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single-Dose Pharmacokinetic (PK) Parameter	Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-8)	Day 1 after dosing
Primary	Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)	AUC from time zero to the time of the last measured concentration	Day 1 after dosing
Primary	Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)	Maximum observed plasma concentration	Day 1 after dosing
Primary	Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)	Time of the maximum observed plasma concentration	Day 1 after dosing
Primary	Multiple-Dose PK Parameter	Maximum concentration during a dosing interval Ct_max	Day 1 after dosing; day 14
Primary	Multiple-Dose PK Parameter: (Ct_min, Day 14)	Minimum concentration during a dosing interval	Day 1 after dosing; day 14
Primary	Multiple-Dose PK Parameter: (AUCtau)	AUC over one dosing interval	Day 1 after dosing; day 14
Primary	To characterize the safety and tolerability of single dose of CS0159	Incidence and severity of adverse events	up to Day 31
Primary	To characterize the safety and tolerability of multiple doses of CS0159	Incidence and severity of adverse events	up to Day 44
Secondary	Pharmacodynamic (PD) Parameter: FGF19	fibroblast growth factor 19	Day -1; day 1
Secondary	Pharmacodynamic (PD) Parameter: C4	serum concentration	Day -1; day 1