Healthy Participants, IBD (Inflammatory Bowel Disease)
Conditions
Brief summary
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
Interventions
DRUGHW201877 capsules
Dose 1 to Dose 7
DRUGPlacebo
Dose 1 to Dose 7
Sponsors
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions. * Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration. * 18 years to 55 years (inclusive), male and female. * Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg/m2 (inclusive) . Key
Exclusion criteria
* Smoking more than 5 cigarettes per day within 3 months prior to screening. * Allergic diathesis (with a history of allergies to multiple drugs and foods). * A history of drug abuse and/or alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine). * Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening. * Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug. * Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug. * Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases). * Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia. * Not suitable for this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | Day 1 to Day 5 | To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers |
Countries
China
Outcome results
None listed