To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Participants must sign the informed consent form prior to the study, fully understand the study, procedures, and potential adverse reactions, and be voluntary participate in and able to complete the study as required by the protocol.
Male or female participants aged 18-45 years (inclusive).
Body weight of not less than 50.00 kg for male participants and 45.00 kg for female participants with body mass index (BMI) within the range of 19.0-27.0 kg/m2 (inclusive).
Female participants of childbearing potential, or male participants whose partners are of childbearing potential, must have no plans for pregnancy, sperm/egg donation from signing the informed consent until 3 months after the last dose, and must be voluntary to use highly effective contraception (including their partners) (non-pharmacological contraception is required during the study).
Having a clinically significant severe disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, pulmonary, immunological, psychiatric, or cardiovascular and cerebrovascular diseases) within 12 months prior to screening.
Participants with clinically significant abnormalities in laboratory tests, physical examination, vital signs, electrocardiogram (ECG), posteroanterior chest X-ray, or abdominal ultrasound.
Female participants who are pregnant or lactating.
Participants with acute illness or requiring concomitant medication from screening to the first dose.
Parallel
TUL108
Drug50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg
Placebo
Drug0.9% Sodium Chloride Injection
TUL108
Drug125 mg、250 mg、500 mg
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
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This trial is not recruiting at the moment. You can still explore other options:
