Healthy Participants
Conditions
Keywords
TYK2 Inhibitor
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
Interventions
DRUGWD-890
Administered P.O.
DRUGWD-890 Tablets Placebo
Administered P.O.
Sponsors
Zhejiang Wenda Pharma Technology LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
SAD and MAD ：Double (Participant,Investigator) FE：Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution at Steady State (Vss/F) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
| Multiple Ascending Dose (MAD) Cohorts: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| Multiple Ascending Dose (MAD) Cohorts: Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| 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 | Days 1 to 5 |
| 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 | Days 1 to 5 |
| 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 | Days 1 to 19 |
| 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 | Days 1 to 19 |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Maximum Observed Plasma Concentration (Cmax) of WD-890； | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12; FE: Days 1 to 5, Days 8 to 12 |
| 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 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12 |
| 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 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
Secondary
| Measure | Time frame |
|---|---|
| Food Effect Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890 | Days 1 to 5, Days 8 to 12, |
| Food Effect Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890 | Days 1 to 5, Days 8 to 12 |
| Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890 | Days 1 to 5, Days 8 to 12, |
Countries
China
Outcome results
None listed