Can a new antibiotic tame tough urinary infections? a safety trial begins
NCT ID NCT07719257
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental antibiotic called TUL108 in healthy volunteers to see if it is safe and how the body processes it. The drug is being developed for complicated urinary tract infections (cUTI), which can be difficult to treat with standard antibiotics. Researchers will give single and multiple doses by IV infusion and monitor for side effects. The study does not yet test whether TUL108 actually cures infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibiotic called TUL108
- What this could lead to
- If safe, TUL108 could become a new treatment option for complicated urinary tract infections, which are often hard to treat due to antibiotic resistance.
- What could go wrong
- This is an early phase 1 trial in healthy people, not patients. It only tests safety and how the drug moves through the body, not whether it actually works against infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital affiliated to Fudan University
Shanghai, China