A Study of Oral YUQ-A1007 in Healthy Volunteers

Launched by ALLIANTHERA (SUZHOU) BIOPHARMACEUTICALS CO., LTD. · Feb 13, 2025

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ClinConnect Summary

This clinical trial is studying a new medication called YUQ-A1007, which is being tested for its safety and how well it is tolerated in healthy volunteers. This is the first time YUQ-A1007 is being tested in humans. Researchers hope that this medication could eventually help treat inflammatory bowel disease (IBD), but first, they need to understand how it behaves in the body and if it is safe for people to take.

To be eligible for this study, participants must be between 18 and 65 years old, in good health, and not have certain medical conditions that could increase risks during the trial. They also need to agree to avoid smoking, drinking alcohol, and consuming caffeine during the study period. Participants can expect to stay at the clinical research unit (CRU) for part of the study, where their health will be monitored closely. This trial is currently looking for volunteers, and their involvement will help advance research on this potential treatment.

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Eligibility criteria

• 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.