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

NCT07719257 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: TUL-TUL108 (Ⅰ-1) 202603
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complicated Urinary Tract Infections(cUTI)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Part1: TUL108

EXPERIMENTAL

A single ascending dose (SAD) of intravenous (IV) TUL108 (50mg\~1500mg)

Drug: TUL108

Part1: Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Part2: TUL108

EXPERIMENTAL

A multiple ascending dose (MAD) of intravenous (IV) TUL108 (125 mg\~500mg q8h)

Drug: TUL108

Part2: Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

0.9% Sodium Chloride Injection

Part1: Placebo; Part2: Placebo

TUL108 DRUG

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

Part1: TUL108

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Zhuhai United Laboratories Co., Ltd.: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, China

Location

Study Officials

• Jing Zhang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang

CONTACT

+86-021-52887926; 13816357098@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)