A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects
- Conditions
- treatment of infections10004018
- Registration Number
- NL-OMON51720
- Lead Sponsor
- Omnix Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
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 < 1% per year, be sexually
inactive or have a sterilized partner during the study and for at least 3
months after the (last) study drug administration. If a hormonal contraceptive
is used, it must have been initiated at least 1 month before the first study
drug administration. Woman of non-childbearing
potential will be confirmed at Screening by fulfilling one of the following
criteria:
* Postmenopausal defined as amenorrhea for at least 12 months following
cessation of all exogenous hormonal treatments and with follicle-stimulating
hormone (FSH) levels >=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.
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) <90
mL/min (young population) of <60 mL/min (elderly population).
3. Any clinically important illness, medical/surgical procedure or trauma
within 4 weeks of the (first) administration of the study drug, as judged by
the PI.
4. Any positive result at Screening for serum hepatitis B surface antigen,
hepatitis C antibody, and human immunodeficiency virus (HIV).
5. Female subject is pregnant or lactating.
6. Abnormal vital signs, after 10 minutes (semi-)supine rest at Screening or on
Day -1, defined as any of the following:
Systolic blood pressure >140 mmHg (young population) or >150 mmHg (elderly
population).
Diastolic blood pressure >90 mmHg.
Heart rate <40 or >100 bpm.
Two (2) re-tests may be performed at Screening or Day -1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Safety and tolerability parameters include: physical examination, infusion<br /><br>site reactions/local tolerability, AEs, clinical laboratory values, vital<br /><br>signs, 12-lead ECG, and renal safety biomarkers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Plasma PK parameters for OMN6 include, but are not limited to: Cmax, Tmax,<br /><br>t1/2, AUC0-last, AUC0-inf, CL, CLss, Vd and Vss.</p><br>