Infection, Bacterial
Conditions
Brief summary
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
Detailed description
This study is a First in Human (FIH) single ascending dose study with XAB05 to evaluate safety, tolerability, PK and exploratory markers of efficacy for XAB05 in healthy volunteers.
Interventions
BIOLOGICALExperimental
Participants will receive a single IV infusion in a double blind manner
Sponsors
QPS Netherlands B.V.
Xenothera SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* .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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability parameters: electrocardiogram (ECG): | From screening through study completion, up to 30 days | Number of Clinically significant abnormal findings recorded by investigator based on HR, PR, QRS, and QT values of ECG |
| Safety and tolerability parameters: physical examination | From screening through study completion, up to 30 days | Number of clinically relevant findings during inspection, percussion, palpation, and auscultation. |
| Safety and tolerability parameters: Adverse events (AEs) | From screening through study completion, up to 30 days | Number of adverse events (AEs) |
| Safety and tolerability parameters :infusion site reactions/local tolerability | From screening through study completion, up to 30 days | Incidence of infusion site reactions/local tolerability |
| Safety and tolerability parameters: clinical laboratory values | From screening through study completion, up to 30 days | Number of clinically significant laboratory abnormalities |
| Safety and tolerability parameters:vital signs - Blood pressure value | From screening through study completion, up to 30 days | Blood pressure (mm Hg) |
| Safety and tolerability parameters:vital signs - Pulse value | From screening through study completion, up to 30 days | pulse rate |
| Safety and tolerability parameters:vital signs -repiratory value | From screening through study completion, up to 30 days | respiration rate |
| Safety and tolerability parameters:vital signs -temperature | From screening through study completion, up to 30 days | temporal body temperature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters for XAB05 : Cmax | From treatment day through study completion, up to 30 days | Maximal Observed concentration (Cmax) |
| PK parameters for XAB05: tmax | From treatment day through study completion, up to 30 days | Time to Cmax |
| PK parameters for XAB05 :Ceoi | From treatment day through study completion, up to 30 days | Concentration at the end of infusion |
| PK parameters for XAB05 : t1/2 | From treatment day through study completion, up to 30 days | Terminal elimination half-life of the drug |
| PK parameters for XAB05 : AUC0-t | From treatment day through study completion, up to 30 days | Area under the concentration-time curve up to the last measurable concentration |
| PK parameters for XAB05 :AUC0-inf | From treatment day through study completion, up to 30 days | Area under the concentration-time curve to infinite time |
| PK parameters for XAB05: CL | From treatment day through study completion, up to 30 days | Clearance of the drug |
| PK parameters for XAB05 : Vz | From treatment day through study completion, up to 30 days | Volume of distribution |
| Immunogenicity parameters | From treatment day through study completion, up to 30 days | concentration of anti-drug antibodies (ADA) |
Countries
Netherlands
Outcome results
None listed