Complicated Urinary Tract Infections(cUTI)
Conditions
Brief summary
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Detailed description
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.
Interventions
DRUGTUL108
50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg
DRUGPlacebo
0.9% Sodium Chloride Injection
Sponsors
Zhuhai United Laboratories Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTJing Zhang
PRINCIPAL_INVESTIGATORJing Zhang
Huashan Hospital
Outcome results
None listed