Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- 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.
Ages Eligible for Study
18 Years to 65 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes