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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complicated Urinary Tract Infections(cUTI)
• Intervention / Treatment: Drug: Placebo; Drug: TUL108; Drug: TUL108

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing Zhang; Phone Number: +86-021-52887926; Email: 13816357098@163.com

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital affiliated to Fudan University
    • Contact: Jing Zhang; Phone Number: +86-021-52887926; Email: 13816357098@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1: TUL108; A single ascending dose (SAD) of intravenous (IV) TUL108 (50mg~1500mg)	Drug: TUL108; 50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg; Drug: TUL108; 125 mg、250 mg、500 mg
Placebo Comparator: Part1: Placebo; Placebo	Drug: Placebo; 0.9% Sodium Chloride Injection
Experimental: Part2: TUL108; A multiple ascending dose (MAD) of intravenous (IV) TUL108 (125 mg~500mg q8h)	Drug: TUL108; 50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg; Drug: TUL108; 125 mg、250 mg、500 mg
Placebo Comparator: Part2: Placebo; Placebo	Drug: Placebo; 0.9% Sodium Chloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Zhuhai United Laboratories Co., Ltd.
• Investigators: Principal Investigator: Jing Zhang, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TUL-TUL108 (Ⅰ-1) 202603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No