None listed
Conditions
Interventions
Cohort 1 (low dose, single dose):Cefepime 1.0g/ VNRX-5133 0.25g or placebo single dose intravenously
Cohort 2 (target dose, single dose):Cefepime 2.0g/VNRX-5133 0.5g or placebo single dose intravenously
Cohort 3 (target dose, multiple doses):Cefepime 2.0g/ VNRX-5133 0.5g or placebo iv, q8h, 10 days
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male/female Chinese subjects between the ages of 18 and 45 years (inclusive) will be enrolled in this trial 2. Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, electrocardiogram (ECG) and laboratory safety tests. 3. Agrees to use highly effective methods of contraception during the study and for 90 days after the last dose of Study Medication. 4. Female subject with a negative result of serum ß-hCG. 5. Agrees to comply with the study procedures and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. Has a history of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. 2. Has a personal history of hypersensitivity to VNRX- 5133 or beta lactam antibiotics (including but not limited to cefepime, meropenem, imipenem, penicillin, cephalosporins, monobactams and other carbapenems). 3. Female subject is lactating or pregnant. 4. Use any investigational drug within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK assessment;Safety assessment; | — |
Countries
China
Contacts
Public ContactKevin Li
Outcome results
None listed