A Phase I Study of HW201877 in Healthy Subjects

NCT07373457 | Recruiting Phase 1

• 1 other identifier: RFIB-I-202501
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

IBD (Inflammatory Bowel Disease); Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HW201877 capsules

EXPERIMENTAL

Single or multiple oral doses of HW201877 capsules, and food effect of HW201877 capsules

Drug: HW201877 capsules

Placebo

PLACEBO COMPARATOR

Single or multiple oral doses of placebo, and food effect of placebo

Drug: Placebo

Interventions

HW201877 capsules DRUG

Dose 1 to Dose 7

HW201877 capsules

Placebo DRUG

Dose 1 to Dose 7

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Hospital of Jilin University

Changchun, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 28, 2026
• Study Start: June 26, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)