A Phase I Study of HW201877 in Healthy Subjects

Wuhan Humanwell Innovative Drug Research and Development Center Limited Company

Status and phase

Enrolling

Phase 1

Conditions

IBD (Inflammatory Bowel Disease)

Healthy Participants

Treatments

Drug: HW201877 capsules

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07373457

RFIB-I-202501

Details and patient eligibility

About

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).

Enrollment

104 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.