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
Primary Objective: To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants. Secondary Objectives: 1. To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants; 2. To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants; 3. To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules; 4. To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants; 5. To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
94
orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg
Oral placebo capsules matching TUL321 capsules
orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITING1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Time frame: up to 17 days
Peak plasma concentration (Cmax)
Time frame: Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax)
Time frame: Pre-dose to 144 hours post-dose
Cumulative amount excreted(Ae)in urine
Time frame: Pre-dose to 144 hours post-dose
Cumulative amount excreted(Ae)in feces
Time frame: Pre-dose to 144 hours post-dose
Alternative pathway (AP) activity
Time frame: Pre-dose to 144 hours post-dose
Bb concentration
Time frame: Pre-dose to 144 hours post-dose
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Oral placebo capsules matching TUL321 capsules