A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Exploratory Markers of Efficacy for XAB05 in Healthy Subjects.
- Conditions
- treatment and the prevention of multidrug resistant (MDR) bacterial infections.10004018
- Registration Number
- NL-OMON50582
- Lead Sponsor
- Xenothera SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1. The subject must understand the nature of the study and must provide signed
and dated written informed consent in accordance with local regulations before
the conduct of any study-related procedures.
2. Healthy as determined by the Investigator, based on a medical evaluation
including medical history, physical examination, laboratory tests and ECG
recording. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied, may be included
only if, in the opinion of the Investigator, the finding is (a) unlikely to
introduce additional risk to the subject, (b) will not interfere with study
procedures or confound study results, and (c) is not otherwise exclusionary
(see Exclusion Criteria).
3. The subject is a male or female, aged 18 to 65 years, inclusive, at
Screening.
4. The subject weighs at least 50 kg and has a BMI between 18.0 and 34.0 kg/m2,
inclusive, at Screening and on Day -1.
5. Women of child-bearing potential must agree not to attempt to become
pregnant and to use a highly effective form of hormonal (oral contraception, a
hormonal implant, hormonal injection or hormonal intra-uterine devices) or
non-hormonal (non-hormonal intra-uterine device/system in combination with a
barrier method (e.g. condom, diaphragm, cervical cap with spermicide)) birth
control or abstinence during the study and for 90 days after the (last) study
drug administration. Postmenopausal women must have had >=12 months of
spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=30
mIU/mL). Surgically sterile women are defined as those who have had a
hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are
surgically sterile must provide documentation of the procedure by an operative
report or by ultrasound. All women must have a negative pregnancy test result
at Screening and on Day -1.
1. The subject has history or evidence of clinically significant hematologic,
dermatologic, neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic,
gastrointestinal, urologic including difficulty voiding, immunologic, endocrine
disease, or psychiatric disorder, or other abnormality, which may impact the
ability of the subject to participate or potentially confound the study
results, or which, in the investigator*s opinion, makes subjects unsuitable for
the study.
2. The subject has a significant history of allergies, as determined by the
Principal Investigator.
3. The subject is taking antihistamines, NSAIDs, or mast cell stabilizers (e.g.
disodium cromoglycate) and is unable to stop taking these medications from 7
days prior to Day 1.
4. The subject has received any prescription or non-prescription drugs
(including steroids and COVID-19 vaccination, but excluding paracetamol, oral
contraception, a hormonal implant or hormonal intra-uterine devices), vitamins
and herbal remedies (including St John*s Wort), within 14 days or 5 half-lives
(whichever is longer) prior to Day -1.
5. A clinically significant abnormality on physical examination, ECG, or
laboratory evaluations at Screening or between Screening and study drug
administration.
6. The subject has a supine blood pressure outside the ranges of 90 to 140 mm
Hg for systolic and 45 to 90 mm Hg for diastolic, confirmed on repeat testing
at Screening and on 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, adverse<br /><br>events (AEs), infusion site reactions/local tolerability, clinical laboratory<br /><br>values, vital signs and electrocardiogram (ECG).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• PK parameters for XAB05 include: Cmax, tmax, Ceoi, t1/2, AUC0-t, AUC0-inf,<br /><br>CL, Vz.<br /><br>• Immunogenicity parameters include: anti-drug antibodies (ADA).</p><br>