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.
Sequential
Part1: TUL321
Drugorally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg
Part1: Placebo
DrugOral placebo capsules matching TUL321 capsules
Part2: TUL321
Drugorally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Part2: Placebo
DrugOral placebo capsules matching TUL321 capsules
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Peak plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Cumulative amount excreted（Ae）in urine
Cumulative amount excreted（Ae）in feces
Click on the lead sponsor to view all of their trials.
