Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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.
Secondary outcome
• Plasma PK parameters for OMN6 include, but are not limited to: Cmax, Tmax,
t1/2, AUC0-last, AUC0-inf, CL, CLss, Vd and Vss.
Background summary
Antimicrobial resistance (AMR) is rapidly spreading worldwide, there is a great
unmet need for new classes of antibiotics to treat drug resistant hospital
associated infections. Multi-drug resistant (MDR) bacteria such as
Acinetobacter baumannii (AB), especially Carbapenem-resistant AB (CRAB), are a
major part of this healthcare challenge. AB is designated number one on the
WHO/CDC pathogen-priority list. Infections are characterized by rapid
development of resistance to multiple classes of antimicrobial drugs used as
standard of care (SoC) including carbapenems. AB has the ability to acquire
resistance through several mechanisms, which has led to the emergence of
strains that are resistant to all commercially available antibiotics. Moreover,
having evolved as a significant hospital pathogen, it has acquired the ability
to resist desiccation and disinfectants. Since their discovery, antibiotics
have served as the cornerstone of modern medicine. AMR has led to the emergence
of untreatable superbugs that are now threatening the basic practice of modern
medicine. A new generation of effective antibiotic drugs is urgently needed.
OMN6 was shown to be highly effective against MDR bacteria. The unique
mechanism of action (MoA) employed by OMN6 demonstrates a complete lack of
resistance or cross-resistance against its antimicrobial activity, allowing
OMN6 to be positioned as a first-line treatment in case of severe and
life-threatening infections. Efficiently eliminating resistant bacteria where
the Standard of Care (SoC) drugs fail, without the fear of losing a new
anti-infective agent due to resistance, OMN6 may provide an alternative to
currently available antimicrobial therapies.
Study objective
Primary objective: To evaluate the safety and tolerability of single ascending
i.v. doses of OMN6 in healthy young and elderly adult subjects.
Secondary objective: To evaluate OMN6 PK in plasma following single ascending
i.v. doses in healthy young and elderly adult subjects.
Study design
In Cohorts 1 to 5, the study drug is planned to be administered as a single
i.v. infusion of 3 hours to healthy young adults. In Cohorts 6 to 9, doses are
planned to be administered as split i.v. infusions to healthy young adults; in
Cohort 6 and 7, the dose will be administered as two 3-hour infusions with 8
hours between start of infusions and in Cohort 8 and 9, the dose will be
administered as three 3-hour infusions with 8 hours between start of infusions.
In Cohort 10, the study drug is planned to be administered as a single 3-hour
i.v. infusion to healthy elderly subjects.
Intervention
OMN6 or matching placebo
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IB for further information.
High-Tech Village Givat Ram Campus N.A.
Jerusalem 91391
NL
High-Tech Village Givat Ram Campus N.A.
Jerusalem 91391
NL
Listed location countries
Age
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 < 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.
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) <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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-001865-18-NL |
| CCMO | NL80298.056.22 |