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NCT07719257
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
Conditions: Complicated Urinary Tract Infections(cUTI)
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 72
Sponsor: Zhuhai United Laboratories Co., Ltd.
Location: Huashan Hospital affiliated to Fudan University Shanghai
Summary
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07719257). StuddyBuddy aggregates publicly available trial information.