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

NCT07719257 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-22

No results posted yet for this study

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)

Interventions

DRUG

TUL108

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

DRUG

Placebo

0.9% Sodium Chloride Injection

DRUG

TUL108

125 mg、250 mg、500 mg

Sponsors & Collaborators

  • Zhuhai United Laboratories Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Zhang · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719257 on ClinicalTrials.gov