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Clinical Trials in China / NCT07719257
Starting soon Phase 1

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

NCT07719257 · tracked via the Priya Life Science China tracker
Sponsor
Zhuhai United Laboratories Co., Ltd.
Phase
Phase 1
Started
2026-07-30
Last updated
2026-07-22

Condition(s) studied

Complicated Urinary Tract Infections(cUTI)

Investigational drug(s) / intervention(s)

TUL108PlaceboTUL108

TUL108: 50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg

Placebo: 0.9% Sodium Chloride Injection

TUL108: 125 mg、250 mg、500 mg

Study summary

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)

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital affiliated to Fudan University Shanghai China

More Zhuhai United Laboratories Co., Ltd. trials in China

Official registry record

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.

View NCT07719257 on ClinicalTrials.gov ↗ ← All trials in China