Clinical trial NCT06117514: Sudapyridine (WX-081) in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Jiatan Pharmatech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Time to reach plasma Cmax (Tmax) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Area under the plasma concentration-time curve (AUC) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Terminal elimination half-life (t½) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Volume of distribution (Vd/F) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Apparent clearance (CL/F) of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Elimination rate constant Ke of Sudapyridine
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
measure: Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
timeFrame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
Study officials:
affiliation: Shanghai Xuhui District Central Hospital
name: Yun Liu
role: PRINCIPAL_INVESTIGATOR
References: