Infection, BacterialPhase 1NCT05307406
A First-in-Human Study With XAB05 in Healthy Subjects
A Phase 1 study testing Experimental in people with Infection, Bacterial, run by Xenothera SAS at 1 site in Netherlands.
Trial summary
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2022to 19 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- .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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
Read the 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.
- Conditions
- Infection, Bacterial
- Being tested
- Experimental
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBiological
Participants will receive a single IV infusion in a double blind manner
| Study group | Role | What they receive |
|---|---|---|
| XAB05 | Experimental | Single ascending dose from 0.25 mg/kg up to 20mg/kg IV infusion Receives: Biological: Experimental |
| Placebo | Placebo comparator | Single IV infusion Receives: Biological: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability parameters: physical examination
Number of clinically relevant findings during inspection, percussion, palpation, and auscultation.
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters: Adverse events (AEs)
Number of adverse events (AEs)
Measured: 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
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters: clinical laboratory values
Number of clinically significant laboratory abnormalities
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs - Blood pressure value
Blood pressure (mm Hg)
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs - Pulse value
pulse rate
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs -repiratory value
respiration rate
Measured: From screening through study completion, up to 30 days
Safety and tolerability parameters:vital signs -temperature
temporal body temperature
Measured: 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
Measured: From screening through study completion, up to 30 days
Secondary outcomes (9)
PK parameters for XAB05 : Cmax
Maximal Observed concentration (Cmax)
Measured: From treatment day through study completion, up to 30 days
PK parameters for XAB05: tmax
Time to Cmax
Measured: From treatment day through study completion, up to 30 days
PK parameters for XAB05 :Ceoi
Concentration at the end of infusion
Measured: From treatment day through study completion, up to 30 days
PK parameters for XAB05 : t1/2
Terminal elimination half-life of the drug
Measured: 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
Measured: 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
Measured: From treatment day through study completion, up to 30 days
PK parameters for XAB05: CL
Clearance of the drug
Measured: From treatment day through study completion, up to 30 days
PK parameters for XAB05 : Vz
Volume of distribution
Measured: From treatment day through study completion, up to 30 days
Immunogenicity parameters
concentration of anti-drug antibodies (ADA)
Measured: From treatment day through study completion, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start24 Jan 2022
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenothera SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Netherlands B.V.
- Responsible party
- Sponsor
- Investigators
- Khadid Abd-Elaziz, MD, Principal investigator, QPS Netherlands B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307406
- Sponsor's protocol ID
- XT-2102
- Status last verified
- Aug 2022
- First submitted
- 17 Feb 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05307406
- Acronym / sponsor ID
- XT-2102
- Conditions
- Infection, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Xenothera SASIndustry (pharma, biotech, devices)
- Collaborators
- QPS Netherlands B.V.
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XAB05 | Experimental | Biological: ExperimentalSingle ascending dose from 0.25 mg/kg up to 20mg/kg IV infusion |
| Placebo | Placebo comparator | Biological: ExperimentalSingle IV infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- .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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalParticipants will receive a single IV infusion in a double blind manner | Biological | Placebo, XAB05 |
Primary outcome
Safety and tolerability parameters: physical examination
Time frame: 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)
Time frame: From screening through study completion, up to 30 days
Number of adverse events (AEs)
Safety and tolerability parameters :infusion site reactions/local tolerability
Time frame: From screening through study completion, up to 30 days
Incidence of infusion site reactions/local tolerability
Safety and tolerability parameters: clinical laboratory values
Time frame: From screening through study completion, up to 30 days
Number of clinically significant laboratory abnormalities
Safety and tolerability parameters:vital signs - Blood pressure value
Time frame: From screening through study completion, up to 30 days
Blood pressure (mm Hg)
Safety and tolerability parameters:vital signs - Pulse value
Time frame: From screening through study completion, up to 30 days
pulse rate
Safety and tolerability parameters:vital signs -repiratory value
Time frame: From screening through study completion, up to 30 days
respiration rate
Safety and tolerability parameters:vital signs -temperature
Time frame: From screening through study completion, up to 30 days
temporal body temperature
Safety and tolerability parameters: electrocardiogram (ECG):
Time frame: 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
9 secondary outcomes
PK parameters for XAB05 : Cmax
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05: tmax
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05 :Ceoi
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05 : t1/2
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05 : AUC0-t
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05 :AUC0-inf
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05: CL
Time frame: From treatment day through study completion, up to 30 days
PK parameters for XAB05 : Vz
Time frame: From treatment day through study completion, up to 30 days
Immunogenicity parameters
Time frame: From treatment day through study completion, up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khadid Abd-Elaziz, MD principal investigator
QPS Netherlands B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental in people with Infection, Bacterial, run by Xenothera SAS at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability parameters: physical examination (time frame: From screening through study completion, up to 30 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.