NCT06117514

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sudapyridine 30mg	Sudapyridine capsule 30mg, orally, single dose
DRUG	Sudapyridine 100mg SAD	Sudapyridine tablet, 100mg orally, single dose
DRUG	Sudapyridine 200mg SAD	Sudapyridine tablet, 200mg orally, single dose
DRUG	Sudapyridine 200mg MAD	Sudapyridine tablet, 200mg orally once a day for 14 days
DRUG	Sudapyridine 300mg MAD	Sudapyridine tablet, 300mg orally once a day for 14 days
OTHER	Placebo tablet SAD	Placebo tablet, 100mg orally, single dose
OTHER	Placebo 200mg SAD	Placebo tablet, 200mg orally, single dose
OTHER	Placebo tablet MAD	Placebo tablet, 200mg orally once a day for 14 days
OTHER	Placebo tablet MAD	Placebo tablet, 300mg orally once a day for 14 days

Timeline

• Start date: 2019-02-13
• Primary completion: 2020-07-02
• Completion: 2020-07-02
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: China