Status:
COMPLETED
Sudapyridine (WX-081) in Healthy Volunteers
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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 (W...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06117514
Start Date
February 13 2019
End Date
July 2 2020
Last Update
November 7 2023
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, China