Complicated Urinary Tract Infections(cUTI)Phase 1NCT07719257
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
A Phase 1 study testing TUL108 in people with Complicated Urinary Tract Infections(cUTI), run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Complicated Urinary Tract Infections(cUTI)
- What is being tested?
- TUL108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital affiliated to Fudan University
Shanghai
Jing Zhang, +86-021-52887926, 13816357098@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TUL108 for Injection After Single and Multiple Intravenous Infusions in Healthy Participants.
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Read the detailed description
Primary Objective:
To evaluate the safety and tolerability of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Secondary Objectives:
- To evaluate the pharmacokinetic (PK) profiles of TUL108 following single and multiple IV infusion in healthy participants.
- To evaluate the effect of IV infusion of TUL108 on QT interval.
- To preliminarily evaluate the human biotransformation and mass balance characteristics following IV infusion of TUL108.
- Being tested
- TUL108, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUL108Drug
50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg
PlaceboDrug
0.9% Sodium Chloride Injection
TUL108Drug
125 mg、250 mg、500 mg
| Study group | Role | What they receive |
|---|---|---|
| Part1: TUL108 | Experimental | A single ascending dose (SAD) of intravenous (IV) TUL108 (50mg~1500mg) Receives: Drug: TUL108 |
| Part1: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part2: TUL108 | Experimental | A multiple ascending dose (MAD) of intravenous (IV) TUL108 (125 mg~500mg q8h) Receives: Drug: TUL108 |
| Part2: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Measured: Day 1 to Day 4
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Measured: Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract Infections(cUTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719257
- Sponsor's protocol ID
- TUL-TUL108 (Ⅰ-1) 202603
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TUL108 for Injection After Single and Multiple Intravenous Infusions in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07719257
- Acronym / sponsor ID
- TUL-TUL108 (Ⅰ-1) 202603
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the pharmacokinetic (PK) profiles of TUL108 following single and multiple IV infusion in healthy participants.
- To evaluate the effect of IV infusion of TUL108 on QT interval.
- To preliminarily evaluate the human biotransformation and mass balance characteristics following IV infusion of TUL108.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part1: TUL108 | Experimental | Drug: TUL108A single ascending dose (SAD) of intravenous (IV) TUL108 (50mg~1500mg) |
| Part1: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part2: TUL108 | Experimental | Drug: TUL108A multiple ascending dose (MAD) of intravenous (IV) TUL108 (125 mg~500mg q8h) |
| Part2: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUL10850 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg | Drug | Part1: TUL108 |
| Placebo0.9% Sodium Chloride Injection | Drug | Part1: Placebo, Part2: Placebo |
| TUL108125 mg、250 mg、500 mg | Drug | Part2: TUL108 |
Primary outcome
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Time frame: Day 1 to Day 4
Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs) etc.
Time frame: Day 1 to Day 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Zhang principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TUL108 in people with Complicated Urinary Tract Infections(cUTI), run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang (+86-021-52887926, 13816357098@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs) etc. (time frame: Day 1 to Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.