A Phase I Study of HW201877 in Healthy Subjects

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Drug: HW201877 capsules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • Recruiting
    • The First Hospital of Jilin University
    • Contact: Hong Zhang, Doctor; Phone Number: +86 13654376192; Email: jhongzhang@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Single or multiple oral doses of placebo, and food effect of placebo	Drug: Placebo; Dose 1 to Dose 7
Experimental: HW201877 capsules; Single or multiple oral doses of HW201877 capsules, and food effect of HW201877 capsules	Drug: HW201877 capsules; Dose 1 to Dose 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number and severity of treatment emergent adverse events (TEAEs)	To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers	Day 1 to Day 5

Collaborators and Investigators

• Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: RFIB-I-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No