Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)

Primary Objective:

To evaluate the safety and tolerability of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.

Secondary Objectives:

• To evaluate the pharmacokinetic (PK) profiles of TUL108 following single and multiple IV infusion in healthy participants.
• To evaluate the effect of IV infusion of TUL108 on QT interval.
• To preliminarily evaluate the human biotransformation and mass balance characteristics following IV infusion of TUL108.

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• Participants who are unable to tolerate venipuncture or have a history of needle phobia or hemophobia.
• Participants who are unsuitable for the study as assessed by the investigator due to any other factors.