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

NCT05307406 | Completed Phase 1 DMC

• 1 other identifier: XT-2102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• PK parameters for XAB05 : Cmax

  From treatment day through study completion, up to 30 days

• PK parameters for XAB05: tmax

  From treatment day through study completion, up to 30 days

• PK parameters for XAB05 :Ceoi

  From treatment day through study completion, up to 30 days

• PK parameters for XAB05 : t1/2

  From treatment day through study completion, up to 30 days

• PK parameters for XAB05 : AUC0-t

  From treatment day through study completion, up to 30 days

Study Arms (2)

XAB05

EXPERIMENTAL

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

Biological: Experimental

Placebo

PLACEBO COMPARATOR

Single IV infusion

Biological: Experimental

Interventions

Experimental BIOLOGICAL

Participants will receive a single IV infusion in a double blind manner

Placebo; XAB05

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. The subject is a male or female, aged 18 to 65 years, inclusive, at Screening.
• \. 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.
• \. 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.
• \. 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.
• \. The subject has a significant history of allergies, as determined by the Principal Investigator.
• \. 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.
• \. 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.
• \. A clinically significant abnormality on physical examination, ECG, or laboratory evaluations at Screening or between Screening and study drug administration.
• \. 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.

Sponsors & Collaborators

• Xenothera SAS: lead
• QPS Netherlands B.V.: collaborator

Study Sites (1)

QPS Netherlands B.V.

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Khadid Abd-Elaziz, MD

  QPS Netherlands B.V.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: April 1, 2022
• Study Start: January 24, 2022
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

NL (1)