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

Sponsor
Cascade Pharmaceuticals, Inc (Other)
Overall Status
Recruiting
CT.gov ID
NCT05082779
Collaborator
Covance (Industry)
80
Enrollment
1
Location
10
Arms
11.2
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 26, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A1: 0.2 mg

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

Drug: CS0159
Tablets administered orally
Other Names:
  • Placebo

    		•
    Experimental: Cohort A2: 0.6 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort A3: 1 mg

    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
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort A4: 2 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort A5: 4 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort A6: 8 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort B1: 0.4 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort B2: 1 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort B3: 2 mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•
    Experimental: Cohort B4: 4mg

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

    Drug: CS0159
    Tablets administered orally
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Single-Dose Pharmacokinetic (PK) Parameter [Day 1 after dosing]

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

    2. Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last) [Day 1 after dosing]

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

    3. Single-Dose Pharmacokinetic (PK) Parameter: (Cmax) [Day 1 after dosing]

      Maximum observed plasma concentration

    4. Single-Dose Pharmacokinetic (PK) Parameter: (Tmax) [Day 1 after dosing]

      Time of the maximum observed plasma concentration

    5. Multiple-Dose PK Parameter [Day 1 after dosing; day 14]

      Maximum concentration during a dosing interval Ct_max

    6. Multiple-Dose PK Parameter: (Ct_min, Day 14) [Day 1 after dosing; day 14]

      Minimum concentration during a dosing interval

    7. Multiple-Dose PK Parameter: (AUCtau) [Day 1 after dosing; day 14]

      AUC over one dosing interval

    8. To characterize the safety and tolerability of single dose of CS0159 [up to Day 31]

      Incidence and severity of adverse events

    9. To characterize the safety and tolerability of multiple doses of CS0159 [up to Day 44]

      Incidence and severity of adverse events

    Secondary Outcome Measures

    1. Pharmacodynamic (PD) Parameter: FGF19 [Day -1; day 1]

      fibroblast growth factor 19

    2. Pharmacodynamic (PD) Parameter: C4 [Day -1; day 1]

      serum concentration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp Clinical Research Unit, Inc. Daytona Beach Florida United States 32117

    Sponsors and Collaborators

    • Cascade Pharmaceuticals, Inc
    • Covance

    Investigators

    • Principal Investigator: Kathleen Doisy, MD, Labcorp Clinical Research Unit, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cascade Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT05082779
    Other Study ID Numbers:
    • CS0159-001
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholangitis
    Cholangitis, Sclerosing

    Study Results

    No Results Posted as of Nov 29, 2021