To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. 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.
2. Male or female participants aged 18-45 years (inclusive).
3. 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).
4. 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:
1. 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.
2. Participants with clinically significant abnormalities in laboratory tests, physical examination, vital signs, electrocardiogram (ECG), posteroanterior chest X-ray, or abdominal ultrasound.
3. Female participants who are pregnant or lactating.
4. Participants with acute illness or requiring concomitant medication from screening to the first dose.
5. Participants who are unable to tolerate venipuncture or have a history of needle phobia or hemophobia.
6. Participants who are unsuitable for the study as assessed by the investigator due to any other factors.
Primary outcome measure(s)
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc. — Day 1 to Day 4
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc. — Day 1 to Day 11
Trial sites (1)
Facility
City
Region
Status
Huashan Hospital affiliated to Fudan University
Shanghai
China
More Zhuhai United Laboratories Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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