Sudapyridine (WX-081) in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / 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; Other: Placebo tablet MAD; Placebo tablet, 300mg orally once a day for 14 days; Other Names: Placebo tablet 300mg MAD
Placebo Comparator: Placebo 300mg multiple doses; Participants received Placebo 300 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; Other: Placebo tablet MAD; Placebo tablet, 300mg orally once a day for 14 days; Other Names: Placebo tablet 300mg MAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Time to reach plasma Cmax (Tmax) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Area under the plasma concentration-time curve (AUC) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Terminal elimination half-life (t½) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Volume of distribution (Vd/F) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Apparent clearance (CL/F) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Elimination rate constant Ke of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)	safety parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

Collaborators and Investigators

• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
• Investigators: Principal Investigator: Yun Liu, Shanghai Xuhui District Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JYB0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No