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

A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Exploratory Markers of Efficacy for XAB05 in Healthy Subjects

This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial
• Intervention / Treatment: Biological: Experimental

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • QPS Netherlands B.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XAB05; Single ascending dose from 0.25 mg/kg up to 20mg/kg IV infusion	Biological: Experimental; Participants will receive a single IV infusion in a double blind manner
Placebo Comparator: Placebo; Single IV infusion	Biological: Experimental; Participants will receive a single IV infusion in a double blind manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability parameters: physical examination	Number of clinically relevant findings during inspection, percussion, palpation, and auscultation.	From screening through study completion, up to 30 days
Safety and tolerability parameters: Adverse events (AEs)	Number of adverse events (AEs)	From screening through study completion, up to 30 days
Safety and tolerability parameters :infusion site reactions/local tolerability	Incidence of infusion site reactions/local tolerability	From screening through study completion, up to 30 days
Safety and tolerability parameters: clinical laboratory values	Number of clinically significant laboratory abnormalities	From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs - Blood pressure value	Blood pressure (mm Hg)	From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs - Pulse value	pulse rate	From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs -repiratory value	respiration rate	From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs -temperature	temporal body temperature	From screening through study completion, up to 30 days
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	From screening through study completion, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters for XAB05 : Cmax	Maximal Observed concentration (Cmax)	From treatment day through study completion, up to 30 days
PK parameters for XAB05: tmax	Time to Cmax	From treatment day through study completion, up to 30 days
PK parameters for XAB05 :Ceoi	Concentration at the end of infusion	From treatment day through study completion, up to 30 days
PK parameters for XAB05 : t1/2	Terminal elimination half-life of the drug	From treatment day through study completion, up to 30 days
PK parameters for XAB05 : AUC0-t	Area under the concentration-time curve up to the last measurable concentration	From treatment day through study completion, up to 30 days
PK parameters for XAB05 :AUC0-inf	Area under the concentration-time curve to infinite time	From treatment day through study completion, up to 30 days
PK parameters for XAB05: CL	Clearance of the drug	From treatment day through study completion, up to 30 days
PK parameters for XAB05 : Vz	Volume of distribution	From treatment day through study completion, up to 30 days
Immunogenicity parameters	concentration of anti-drug antibodies (ADA)	From treatment day through study completion, up to 30 days

Collaborators and Investigators

• Sponsor: Xenothera SAS
• Collaborators: QPS Netherlands B.V.
• Investigators: Principal Investigator: Khadid Abd-Elaziz, MD, QPS Netherlands B.V.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): May 19, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: XT-2102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No