A Phase I Study of HW201877 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HW201877 capsules, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants, IBD (Inflammatory Bowel Disease). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.
Overview
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
- Drug HW201877 capsules
Dose 1 to Dose 7 - Drug Placebo
Dose 1 to Dose 7
Primary outcome measures
- The number and severity of treatment emergent adverse events (TEAEs) [Time frame: Day 1 to Day 5]
Eligibility criteria
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) .
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT07373457 · RFIB-I-202501