A Study of Oral YUQ-A1007 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 has the potential to treat IBD. YUQ-A1007 has not been evaluated in human clinical studies. This study is first-in-human (FIH) study of YUQ-A1007. The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.

Key facts

Study ID

NCT06835296

Run by

Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.

People needed

47

Starts

2025-03-20

Expected to finish

2025-09-30

Last updated by the study team

2025-12-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent prior to the conduct of any study-related assessments.
• Aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
• Male and Female participants.
• 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.
• With normal liver and kidney functions.
• 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.
• Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation.
• 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.
• Is in good health based on the medical history, physical examination, vital signs measurements, laboratory tests, and 12-lead ECGs performed at screening.

You may not qualify if…

• Any condition that places the participant at significantly increased risk or may compromise the study objectives.
• Is mentally or legally incapacitated at screening.
• History of malignant neoplasms or carcinoma in situ.
• Has a current or chronic history of liver disease or known hepatic or biliary abnormalities.
• Has had symptomatic herpes zoster.
• Has a history of any known relevant allergy/hypersensitivity or intolerance.
• Has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
• Has a sensitivity to heparin or history of heparin-induced thrombocytopenia.
• Has a clinically significant infection.
• Any history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological.
• Has a clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study.
• Any clinically significant abnormality identified in the physical examination (including vital signs) or electrocardiographic testing.
• 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.
• Has active or latent tuberculosis (TB), regardless of treatment history, or positive diagnostic TB test at screening.
• 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.
• Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
• Has donated or lost blood or blood products in volumes of 450 mL or more within 30 days.
• Has had prior exposure to YUQ-A1007.
• 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.
• 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.
• 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.

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States

Full record on ClinicalTrials.gov

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