Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TUL108, Placebo, TUL108.
- Who it may be relevant to
- Registry conditions: Complicated Urinary Tract Infections(cUTI). Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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:
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.
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
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT07719257 · TUL-TUL108 (Ⅰ-1) 202603