New Gut-Targeting drug takes first step in human trials

NCT ID NCT06835296

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new oral drug called YUQ-A1007 in 47 healthy adults aged 18 to 65. The drug is designed to activate a protein in the gut that may help treat inflammatory bowel disease (IBD). The main goal was to check the drug's safety, tolerability, and how the body processes it. Since this is the first time the drug has been given to humans, no conclusions about its effectiveness for IBD can be drawn yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
YUQ-A1007 (an oral drug that activates a protein called AhR in the gut)
What this could lead to
If safe and well-tolerated, this could pave the way for future studies testing YUQ-A1007 as a treatment for inflammatory bowel disease (IBD).
What could go wrong
This is a very early, first-in-human study in only 47 healthy people. It is designed only to check safety, not to see if the drug works for any disease. Many early-stage drugs fail to show benefit in later trials.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

47 people

The number who actually took part.

Started

Mar 2025

Finished

Sep 2025

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Inclusion Criteria: 1. Written informed consent prior to the conduct of any study-related assessments. 2. Aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF). 3. Male and Female participants. 4. Has body mass index (BMI) as 18.5-27.9 kg/m2 with total body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants at screening. 5. With normal liver and kidney functions. 6. With normal results of clinical laboratory tests or abnormal results of clinical laboratory tests deemed not clinically significant as per investigator judgement at screening and on admission to the CRU. 7. Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation. 8. Agrees not to smoke, vape, or consume tobacco or other nicotine-containing products, not to consume alcohol, not to consume beverages containing caffeine or other xanthines. 9. Is in good health based on the medical history, physical examination, vital signs measurements, laboratory tests, and 12-lead ECGs performed at screening. Exclusion Criteria: 1. Any condition that places the participant at significantly increased risk or may compromise the study objectives. 2. Is mentally or legally incapacitated at screening. 3. History of malignant neoplasms or carcinoma in situ. 4. Has a current or chronic history of liver disease or known hepatic or biliary abnormalities. 5. Has had symptomatic herpes zoster. 6. Has a history of any known relevant allergy/hypersensitivity or intolerance. 7. Has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. 8. Has a sensitivity to heparin or history of heparin-induced thrombocytopenia. 9. Has a clinically significant infection. 10. Any history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological. 11. Has a clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study. 12. Any clinically significant abnormality identified in the physical examination (including vital signs) or electrocardiographic testing. 13. Has a positive test for the presence of human immunodeficiency virus (HIV), hepatitis C antibody, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of investigational product. 14. Has active or latent tuberculosis (TB), regardless of treatment history, or positive diagnostic TB test at screening. 15. Has received treatment with a live, attenuated vaccine within 4 weeks prior to the first dose of investigational product or anticipation of need for such a vaccine during study participation. 16. Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access. 17. Has donated or lost blood or blood products in volumes of 450 mL or more within 30 days. 18. Has had prior exposure to YUQ-A1007. 19. Has participated in a study of any investigational drug, device, biologic, or other agent within 30 days or 5 half-lives prior to screening, whichever is longer. 20. Has received any prescription medications, over-the-counter medications, herbal supplements, or vitamins within 30 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product. 21. Is an employee or has a family member who is an employee of the CRU and is involved in the conduct of the study and/or supervised by the investigator; or is an employee or has a family member who is an employee of the sponsor.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

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