To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Primary Objective: To evaluate the safety and tolerability of single and multiple intravenous (IV) infusion of TUL108 in healthy participants. Secondary Objectives: 1. To evaluate the pharmacokinetic (PK) profiles of TUL108 following single and multiple IV infusion in healthy participants. 2. To evaluate the effect of IV infusion of TUL108 on QT interval. 3. To preliminarily evaluate the human biotransformation and mass balance characteristics following IV infusion of TUL108.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Huashan Hospital affiliated to Fudan University
Shanghai, China
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Time frame: Day 1 to Day 4
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Time frame: Day 1 to Day 11
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