A Phase I Study of HW201877 in Healthy Subjects
Phase 1 · Testing HW201877 capsules · 1 site · Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing HW201877 capsules (a drug) as a possible treatment. Condition(s) listed: Healthy Participants and IBD (Inflammatory Bowel Disease).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 55
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 104 participants are expected to take part.
- Start date: 2025-06-26.
- Main results expected around 2026-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The number and severity of treatment emergent adverse events (TEAEs) (Day 1 to Day 5)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Healthy Participants; IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Wuhan Humanwell Innovative Drug Research and Development Center Limited Company |
| Enrollment | 104 (estimated) |
| Start date | 2025-06-26 |
| Primary completion (est.) | 2026-03 |
| First posted | 2026-01-28 |
| Last updated | 2026-01-28 |
| 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. |
| ClinicalTrials.gov ID | NCT07373457 |
Interventions
- HW201877 capsules (Drug)
Dose 1 to Dose 7 - Placebo (Drug)
Dose 1 to Dose 7
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University | Changchun | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.