Clinical trial NCT06506591: A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects
Official title: A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: TYK2 Inhibitor
Lead sponsor: Zhejiang Wenda Medical Technology Co., Ltd.
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-890 Tablets in Healthy Chinese Subjects


Eligibility criteria: Inclusion Criteria：

* Signed Informed Consent.
* 18 Years to 50 Years (Adult).
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive, and total body weight ：male \>=50 kg; female \>= 45.0 kg.

Exclusion Criteria：

* Has any surgery performed within 6 months prior to screening, or during the study period.
* Inability to swallow solid tablets.
* Inability to be venipunctured and tolerate venous access.

Primary outcomes:
measure: Safety of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
timeFrame: Days 1 to 5
measure: Tolerability of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
timeFrame: Days 1 to 5
measure: Safety of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
timeFrame: Days 1 to 19
measure: Tolerability of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
timeFrame: Days 1 to 19
measure: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Maximum Observed Plasma Concentration (Cmax) of WD-890；
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12; FE: Days 1 to 5, Days 8 to 12
measure: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of WD-890
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12
measure: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of WD-890
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12
measure: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
measure: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
measure: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890
timeFrame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
measure: Multiple Ascending Dose (MAD) Cohorts: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of WD-890
timeFrame: Day 1, Day 6, Day 9 and Day 12
measure: Multiple Ascending Dose (MAD) Cohorts: Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of WD-890
timeFrame: Day 1, Day 6, Day 9 and Day 12
measure: Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution at Steady State (Vss/F) of WD-890
timeFrame: Day 1, Day 6, Day 9 and Day 12
Secondary outcomes:
measure: Food Effect Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890
timeFrame: Days 1 to 5, Days 8 to 12,
measure: Food Effect Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890
timeFrame: Days 1 to 5, Days 8 to 12
measure: Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890
timeFrame: Days 1 to 5, Days 8 to 12,
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: