New IBD drug candidate begins first human safety tests
NCT ID NCT07373457
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is testing an experimental drug called HW201877 in 104 healthy adults to see if it is safe and how the body processes it. The drug is being developed for inflammatory bowel disease (IBD), but this trial does not involve people with IBD. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and measure drug levels in the body.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Hospital of Jilin University
RECRUITINGChangchun, China
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