treatment of infections
Conditions
Interventions
OMN6 or matching placebo
Sponsors
Omnix Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated, written informed consent prior to any study-specific procedures. 2. Healthy male and female subjects aged 18 to 59 years (young population), inclusive, or 60 years and older (elderly population) at the time of Screening. 3. A body mass index (BMI) between 18.0 to 28.0 kg/m2, inclusive at Screening. 4. Females must have a negative pregnancy test at Screening and on Day -1. Woman of childbearing potential must be willing to use a highly effective method of contraception with a failure rate of =30 mIU/mL. OR * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. 5. Male subjects should be willing to use acceptable methods of double barrier contraception i.e., condoms and spermicide, from Day 1 until at least 3 months after the (last) study drug administration. 6. Male subjects must not donate sperm from Day 1 until at least 3 months after the (last) study drug administration.
Exclusion criteria
Exclusion criteria: 1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study. 2. Subject has creatinine clearance (according to Cockcroft-Gault formula) 140 mmHg (young population) or >150 mmHg (elderly population). Diastolic blood pressure >90 mmHg. Heart rate 100 bpm. Two (2) re-tests may be performed at Screening or Day -1.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Plasma PK parameters for OMN6 include, but are not limited to: Cmax, Tmax, t1/2, AUC0-last, AUC0-inf, CL, CLss, Vd and Vss. | — |
Primary
| Measure | Time frame |
|---|---|
| • Safety and tolerability parameters include: physical examination, infusion site reactions/local tolerability, AEs, clinical laboratory values, vital signs, 12-lead ECG, and renal safety biomarkers. | — |
Countries
Netherlands
Outcome results
None listed