Sudapyridine (WX-081) in Healthy Volunteers

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sudapyridine 30mg
* Drug: Sudapyridine 100mg SAD
* Drug: Sudapyridine 200mg SAD
* Drug: Sudapyridine 200mg MAD
* Drug: Sudapyridine 300mg MAD
* Other: Placebo tablet SAD
* Other: Placebo 200mg SAD
* Other: Placebo tablet MAD
* Other: Placebo tablet MAD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sudapyridine 30 mg single dose<br>Participants received Sudapyridine 30 mg single dose orally. | Drug: Sudapyridine 30mg<br>* Sudapyridine capsule 30mg, orally, single dose<br>* Other names: Sudapyridine capsule 30mg SAD;|
| Experimental: Sudapyridine 100 mg single dose<br>Participants received Sudapyridine 100 mg single dose orally. | Drug: Sudapyridine 100mg SAD<br>* Sudapyridine tablet, 100mg orally, single dose<br>* Other names: Sudapyridine tablet 100mg SAD;|
| Experimental: Sudapyridine 200 mg single dose<br>Participants received Sudapyridine 200 mg single dose orally. | Drug: Sudapyridine 200mg SAD<br>* Sudapyridine tablet, 200mg orally, single dose<br>* Other names: Sudapyridine tablet 200mg SAD;|
| Experimental: Sudapyridine 200 mg multiple doses<br>Participants received Sudapyridine 200 mg orally for multiple doses. | Drug: Sudapyridine 200mg MAD<br>* Sudapyridine tablet, 200mg orally once a day for 14 days<br>* Other names: Sudapyridine tablet 200mg MAD;|
| Experimental: Sudapyridine 300 mg multiple doses<br>Participants received Sudapyridine 300 mg orally for multiple doses. | Drug: Sudapyridine 300mg MAD<br>* Sudapyridine tablet, 300mg orally once a day for 14 days<br>* Other names: Sudapyridine tablet 300mg MAD;|
| Placebo Comparator: Placebo 100 mg single dose<br>Participants received Placebo 100 mg single dose orally. | Other: Placebo tablet SAD<br>* Placebo tablet, 100mg orally, single dose<br>* Other names: Placebo tablet 100mg;|
| Placebo Comparator: Placebo 200 mg single dose<br>Participants received Placebo 200 mg single dose orally. | Other: Placebo 200mg SAD<br>* Placebo tablet, 200mg orally, single dose<br>|
| Placebo Comparator: Placebo 200 mg multiple doses<br>articipants received Placebo 200 mg orally for multiple doses. | Other: Placebo tablet MAD<br>* Placebo tablet, 200mg orally once a day for 14 days<br>* Other names: Placebo tablet 200mg MAD;|
| Placebo Comparator: Placebo 300mg multiple doses<br>Participants received Placebo 300 mg orally for multiple doses. | Other: Placebo tablet MAD<br>* Placebo tablet, 300mg orally once a day for 14 days<br>* Other names: Placebo tablet 300mg MAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Time to reach plasma Cmax (Tmax) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Area under the plasma concentration-time curve (AUC) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Terminal elimination half-life (t½) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Volume of distribution (Vd/F) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Apparent clearance (CL/F) of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Elimination rate constant Ke of Sudapyridine | PK parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | 
| Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs) | safety parameter | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose |