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Sudapyridine (WX-081) in Healthy Volunteers

Sponsor
Shanghai Jiatan Pharmatech Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT06117514
Collaborator
(none)
82
Enrollment
1
Location
9
Arms
16.6
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sudapyridine 30mg
  • Drug: Sudapyridine 100mg SAD
  • Drug: Sudapyridine 200mg SAD
  • Drug: Sudapyridine 200mg MAD
  • Drug: Sudapyridine 300mg MAD
  • Other: Placebo tablet SAD
  • Other: Placebo 200mg SAD
  • Other: Placebo tablet MAD
  • Other: Placebo tablet MAD
 Phase 1

Detailed Description

In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.

This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-ascending Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Sudapyridine (WX-081) Tablets in Healthy Chinese Subjects
Actual Study Start Date :
Feb 13, 2019
Actual Primary Completion Date :
Jul 2, 2020
Actual Study Completion Date :
Jul 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sudapyridine 30 mg single dose

Participants received Sudapyridine 30 mg single dose orally.

Drug: Sudapyridine 30mg
Sudapyridine capsule 30mg, orally, single dose
Other Names:
  • Sudapyridine capsule 30mg SAD

    		•
    Experimental: Sudapyridine 100 mg single dose

    Participants received Sudapyridine 100 mg single dose orally.

    Drug: Sudapyridine 100mg SAD
    Sudapyridine tablet, 100mg orally, single dose
    Other Names:
  • Sudapyridine tablet 100mg SAD

    		•
    Experimental: Sudapyridine 200 mg single dose

    Participants received Sudapyridine 200 mg single dose orally.

    Drug: Sudapyridine 200mg SAD
    Sudapyridine tablet, 200mg orally, single dose
    Other Names:
  • Sudapyridine tablet 200mg SAD

    		•
    Experimental: Sudapyridine 200 mg multiple doses

    Participants received Sudapyridine 200 mg orally for multiple doses.

    Drug: Sudapyridine 200mg MAD
    Sudapyridine tablet, 200mg orally once a day for 14 days
    Other Names:
  • Sudapyridine tablet 200mg MAD

    		•
    Experimental: Sudapyridine 300 mg multiple doses

    Participants received Sudapyridine 300 mg orally for multiple doses.

    Drug: Sudapyridine 300mg MAD
    Sudapyridine tablet, 300mg orally once a day for 14 days
    Other Names:
  • Sudapyridine tablet 300mg MAD

    		•
    Placebo Comparator: Placebo 100 mg single dose

    Participants received Placebo 100 mg single dose orally.

    Other: Placebo tablet SAD
    Placebo tablet, 100mg orally, single dose
    Other Names:
  • Placebo tablet 100mg

    		•
    Placebo Comparator: Placebo 200 mg single dose

    Participants received Placebo 200 mg single dose orally.

    Other: Placebo 200mg SAD
    Placebo tablet, 200mg orally, single dose
    Placebo Comparator: Placebo 200 mg multiple doses

    articipants received Placebo 200 mg orally for multiple doses.

    Other: Placebo tablet MAD
    Placebo tablet, 200mg orally once a day for 14 days
    Other Names:
  • Placebo tablet 200mg MAD

    		•
    Placebo Comparator: Placebo 300mg multiple doses

    Participants received Placebo 300 mg orally for multiple doses.

    Other: Placebo tablet MAD
    Placebo tablet, 300mg orally once a day for 14 days
    Other Names:
  • Placebo tablet 300mg MAD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum plasma concentration (Cmax) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    2. Time to reach plasma Cmax (Tmax) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    3. Area under the plasma concentration-time curve (AUC) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    4. Terminal elimination half-life (t½) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    5. Volume of distribution (Vd/F) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    6. Apparent clearance (CL/F) of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    7. Elimination rate constant Ke of Sudapyridine [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      PK parameter

    8. Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs) [0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose]

      safety parameter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Weight: ≥50 kg; 19≤ body mass index (BMI) < 26 kg/m2;

    • Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;

    • No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.

    Exclusion Criteria:

    • Allergic to any drug of the same category or its ingredients;

    • A history of alcohol dependence or drug abuse;

    • Laboratory obvious abnormalities;

    • CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;

    • Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Xuhui District Central Hospital Shanghai China

    Sponsors and Collaborators

    • Shanghai Jiatan Pharmatech Co., Ltd

    Investigators

    • Principal Investigator: Yun Liu, Shanghai Xuhui District Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Jiatan Pharmatech Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT06117514
    Other Study ID Numbers:
    • JYB0101
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 7, 2023