Sudapyridine (WX-081) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sudapyridine 30mg; Drug: Sudapyridine 200mg MAD; Other: Placebo tablet MAD; Drug: Sudapyridine 300mg MAD; Other: Placebo 200mg SAD; Other: Placebo tablet SAD; Drug: Sudapyridine 100mg SAD; Drug: Sudapyridine 200mg SAD

• Registration Number: NCT06117514
• Lead Sponsor: Shanghai Jiatan Pharmatech Co., Ltd

Brief Summary

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

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 Timeline

• Study Start: 2019-02-13
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2023-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sudapyridine 30 mg single dose	Sudapyridine 30mg	Participants received Sudapyridine 30 mg single dose orally.
Sudapyridine 200 mg multiple doses	Sudapyridine 200mg MAD	Participants received Sudapyridine 200 mg orally for multiple doses.
Placebo 200 mg multiple doses	Placebo tablet MAD	articipants received Placebo 200 mg orally for multiple doses.
Sudapyridine 300 mg multiple doses	Sudapyridine 300mg MAD	Participants received Sudapyridine 300 mg orally for multiple doses.
Placebo 200 mg single dose	Placebo 200mg SAD	Participants received Placebo 200 mg single dose orally.
Placebo 100 mg single dose	Placebo tablet SAD	Participants received Placebo 100 mg single dose orally.
Placebo 300mg multiple doses	Placebo tablet MAD	Participants received Placebo 300 mg orally for multiple doses.
Sudapyridine 100 mg single dose	Sudapyridine 100mg SAD	Participants received Sudapyridine 100 mg single dose orally.
Sudapyridine 200 mg single dose	Sudapyridine 200mg SAD	Participants received Sudapyridine 200 mg single dose orally.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Shanghai Xuhui District Central Hospital; 🇨🇳 Shanghai, China