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A First-in-Human Study With XAB05 in Healthy Subjects

Primary Purpose

Infection, Bacterial

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Experimental
Sponsored by
Xenothera SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Bacterial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • QPS Netherlands B.V.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

XAB05

Placebo

Arm Description

Single ascending dose from 0.25 mg/kg up to 20mg/kg IV infusion

Single IV infusion

Outcomes

Primary Outcome Measures

Safety and tolerability parameters: physical examination
Number of clinically relevant findings during inspection, percussion, palpation, and auscultation.
Safety and tolerability parameters: Adverse events (AEs)
Number of adverse events (AEs)
Safety and tolerability parameters :infusion site reactions/local tolerability
Incidence of infusion site reactions/local tolerability
Safety and tolerability parameters: clinical laboratory values
Number of clinically significant laboratory abnormalities
Safety and tolerability parameters:vital signs - Blood pressure value
Blood pressure (mm Hg)
Safety and tolerability parameters:vital signs - Pulse value
pulse rate
Safety and tolerability parameters:vital signs -repiratory value
respiration rate
Safety and tolerability parameters:vital signs -temperature
temporal body temperature
Safety and tolerability parameters: electrocardiogram (ECG):
Number of Clinically significant abnormal findings recorded by investigator based on HR, PR, QRS, and QT values of ECG

Secondary Outcome Measures

PK parameters for XAB05 : Cmax
Maximal Observed concentration (Cmax)
PK parameters for XAB05: tmax
Time to Cmax
PK parameters for XAB05 :Ceoi
Concentration at the end of infusion
PK parameters for XAB05 : t1/2
Terminal elimination half-life of the drug
PK parameters for XAB05 : AUC0-t
Area under the concentration-time curve up to the last measurable concentration
PK parameters for XAB05 :AUC0-inf
Area under the concentration-time curve to infinite time
PK parameters for XAB05: CL
Clearance of the drug
PK parameters for XAB05 : Vz
Volume of distribution
Immunogenicity parameters
concentration of anti-drug antibodies (ADA)

Full Information

First Posted
February 17, 2022
Last Updated
August 11, 2022
Sponsor
Xenothera SAS
Collaborators
QPS Netherlands B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05307406
Brief Title
A First-in-Human Study With XAB05 in Healthy Subjects
Official Title
A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Exploratory Markers of Efficacy for XAB05 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenothera SAS
Collaborators
QPS Netherlands B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XAB05
Arm Type
Experimental
Arm Description
Single ascending dose from 0.25 mg/kg up to 20mg/kg IV infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single IV infusion
Intervention Type
Biological
Intervention Name(s)
Experimental
Intervention Description
Participants will receive a single IV infusion in a double blind manner
Primary Outcome Measure Information:
Title
Safety and tolerability parameters: physical examination
Description
Number of clinically relevant findings during inspection, percussion, palpation, and auscultation.
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters: Adverse events (AEs)
Description
Number of adverse events (AEs)
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters :infusion site reactions/local tolerability
Description
Incidence of infusion site reactions/local tolerability
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters: clinical laboratory values
Description
Number of clinically significant laboratory abnormalities
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters:vital signs - Blood pressure value
Description
Blood pressure (mm Hg)
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters:vital signs - Pulse value
Description
pulse rate
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters:vital signs -repiratory value
Description
respiration rate
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters:vital signs -temperature
Description
temporal body temperature
Time Frame
From screening through study completion, up to 30 days
Title
Safety and tolerability parameters: electrocardiogram (ECG):
Description
Number of Clinically significant abnormal findings recorded by investigator based on HR, PR, QRS, and QT values of ECG
Time Frame
From screening through study completion, up to 30 days
Secondary Outcome Measure Information:
Title
PK parameters for XAB05 : Cmax
Description
Maximal Observed concentration (Cmax)
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05: tmax
Description
Time to Cmax
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05 :Ceoi
Description
Concentration at the end of infusion
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05 : t1/2
Description
Terminal elimination half-life of the drug
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05 : AUC0-t
Description
Area under the concentration-time curve up to the last measurable concentration
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05 :AUC0-inf
Description
Area under the concentration-time curve to infinite time
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05: CL
Description
Clearance of the drug
Time Frame
From treatment day through study completion, up to 30 days
Title
PK parameters for XAB05 : Vz
Description
Volume of distribution
Time Frame
From treatment day through study completion, up to 30 days
Title
Immunogenicity parameters
Description
concentration of anti-drug antibodies (ADA)
Time Frame
From treatment day through study completion, up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khadid Abd-Elaziz, MD
Organizational Affiliation
QPS Netherlands B.V.
Official's Role
Principal Investigator
Facility Information:
Facility Name
QPS Netherlands B.V.
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

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A First-in-Human Study With XAB05 in Healthy Subjects

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