Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK
Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
Age 18-45 years (inclusive) at informed consent, male or female.
Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
Past history of tuberculosis infection or active tuberculosis at screening.
Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.