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

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Complicated Urinary Tract Infections(cUTI)

In brief

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

Key facts

Study ID

NCT07719257

Run by

Zhuhai United Laboratories Co., Ltd.

People needed

72

Starts

2026-07-30

Expected to finish

2026-12-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Huashan Hospital affiliated to Fudan University — Shanghai, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.