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

NCT05082779 | Completed Phase 1 FDA Drug

• 1 other identifier: CS0159-001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Outcome Measures

Primary Outcomes (9)

• Single-Dose Pharmacokinetic (PK) Parameter

  Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞)

  Day 1 after dosing

• Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)

  AUC from time zero to the time of the last measured concentration

  Day 1 after dosing

• Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)

  Maximum observed plasma concentration

  Day 1 after dosing

• Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)

  Time of the maximum observed plasma concentration

  Day 1 after dosing

• Multiple-Dose PK Parameter

  Maximum concentration during a dosing interval Ct\_max

  Day 1 after dosing; day 14

• Multiple-Dose PK Parameter: (Ct_min, Day 14)

  Minimum concentration during a dosing interval

  Day 1 after dosing; day 14

• Multiple-Dose PK Parameter: (AUCtau)

  AUC over one dosing interval

  Day 1 after dosing; day 14

• To characterize the safety and tolerability of single dose of CS0159

  Incidence and severity of adverse events

  up to Day 31

• To characterize the safety and tolerability of multiple doses of CS0159

  Incidence and severity of adverse events

  up to Day 44

Secondary Outcomes (2)

• Pharmacodynamic (PD) Parameter: FGF19

  Day -1; day 1

• Pharmacodynamic (PD) Parameter: C4

  Day -1; day 1

Study Arms (10)

Cohort A1: 0.2 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.

Drug: CS0159

Cohort A2: 0.6 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.

Drug: CS0159

Cohort A3: 1 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 1 mg or placebo once on Day 1 followed by a 7-day washout period then given in 1 mg tablet (in fed state) on Day 8.

Drug: CS0159

Cohort A4: 2 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.

Drug: CS0159

Cohort A5: 4 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.

Drug: CS0159

Cohort A6: 8 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.

Drug: CS0159

Cohort B1: 0.4 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.

Drug: CS0159

Cohort B2: 1 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.

Drug: CS0159

Cohort B3: 2 mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.

Drug: CS0159

Cohort B4: 4mg

EXPERIMENTAL

Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.

Drug: CS0159

Interventions

CS0159 DRUG

Tablets administered orally

Also known as: Placebo

Cohort A1: 0.2 mg; Cohort A2: 0.6 mg; Cohort A3: 1 mg; Cohort A4: 2 mg; Cohort A5: 4 mg; Cohort A6: 8 mg; Cohort B1: 0.4 mg; Cohort B2: 1 mg; Cohort B3: 2 mg; Cohort B4: 4mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and non-pregnant female volunteers
• 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

You may not qualify if:

• Subjects with special dietary requirements and cannot follow a uniform diet.
• Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
• Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
• 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.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead
• Covance: collaborator

Study Sites (1)

Labcorp Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Kathleen Doisy, MD

  Labcorp Clinical Research Unit, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 19, 2021
• Study Start: October 26, 2021
• Primary Completion: September 16, 2022
• Study Completion: October 12, 2022
• Last Updated: October 18, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)