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Sudapyridine (WX-081) in Healthy Volunteers

NCT06117514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-11-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yun Liu · Shanghai Xuhui District Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2020-07-02
Completion
2020-07-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117514 on ClinicalTrials.gov