Safety and Pharmacokinetics (PK) Study of Natrunix in Healthy Volunteers

A Phase 1 study testing Natrunix in people with Pharmacokinetics, run by XBiotech, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This trial will be a Phase I open-label, placebo-controlled dose escalation study to evaluate safety and pharmacokinetics of Natrunix via subcutaneous injection in healthy subjects. The target enrollment is 8 healthy subjects per cohort (including six for Natrunix and two for placebo). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Natrunix
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2022to 8 Aug 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age: ≥ 18
Adequate bone marrow function defined as:
absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
platelet count > 150,000/mm3
hemoglobin of ≥ 10 g/dL
Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.

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Adequate hepatic function defined as:
serum albumin ≥ 3.0 g/dL
total bilirubin ≤ 1.5 times lab ULN.
alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
aspartate aminotransferase (AST) ≤ 2.0 times lab ULN
For WOCBP, a negative pregnancy test at screening. For subjects with reproductive potential, willingness to use one method of contraception of high efficacy during the entire study period. These methods can include but not limited to hormonal contraceptives, intrauterine devices, condoms, diaphragms etc. Women of non-childbearing potential include those considered to have a medical history that indicates that pregnancy is not a reasonable risk, including post-menopausal women and those with a history of hysterectomy or surgically sterilized.
If the participant is a male participating in this clinical research study, the subject should not get a sexual partner pregnant during participation in this research study as the effect of the study drug on sperm is not known. The male contraception methods can include but not limited to mechanical methods (abstinence, withdrawal, non-vaginal intercourse) or contemporary methods comprising condoms and vasectomy.
Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.

Who cannot join

Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
Uncontrolled or significant cardiovascular disease, including:
A myocardial infarction within the past 6 months.
Uncontrolled angina within the past 3 months.
Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Class II or higher.
Uncontrolled hypertension (blood pressure >160 mm Hg systolic or >100 mm Hg diastolic).

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Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, cerebrovascular accident within three months, ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participating in the trial.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
Abnormal ECG with any clinically significant findings or with QTc > 470 ms.
Infection requiring treatment with antibiotics within 3 weeks prior to screening.
Infectious disease:
Positive HIV, RPR, Hepatitis B or C, TB (QuantiFERON-TB Gold (QFT)/ IGRA)
History of immunodeficiency.
Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
Major surgery within 28 days prior to Day 0.
History of progressive multifocal leukoencephalopathy (PML) or other demyelinating disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

BioBehavioral Research of Austin, A Telemed2U Company
Austin, Texas, 78759

Other trials in United States

About this study

Official title: A Phase I Open-label, Placebo-controlled Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Natrunix Via Subcutaneous Injection in Healthy Subjects

Read the detailed description

Study Title: A Phase I open-label, placebo-controlled dose escalation study to evaluate safety and pharmacokinetics of Natrunix via subcutaneous injection in healthy subjects.

Sponsor: XBiotech USA, Inc.

Study Chair: Neha Reshamwala, MD

Number of Planned Subjects: Eight healthy subjects per cohort (including six for Natrunix and two for placebo). Three cohorts for a total of 24 healthy volunteers.

Approximate Duration: Approximately 38 days for each subject which includes a screening period of up to 10 days followed by one subcutaneous dose of Natrunix, and then evaluation over 28 days. Blood will be sampled at various time points for blood chemistry, hematological analysis, and Natrunix serum/plasma concentrations.

Conditions: Pharmacokinetics
Being tested: Natrunix, Placebo
Keywords: Safety, Pharmacokinetics, Dose escalation study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NatrunixBiological
The active ingredient in the drug product Natrunix is XB2001, a recombinant human Immunoglobulin G4 monoclonal antibody specific for human interleukin-1-alpha (IL-1-alpha). The entire XB2001 heavy and light chain sequences are identical to those found in naturally-occurring humans, with the light and heavy chain variable regions being identical to those originally expressed by a peripheral blood B lymphocyte that was obtained from a healthy individual.
PlaceboBiological
Placebo control for Natrunix subcutaneous injection.

Study groups in NCT05099510
Study group	Role	What they receive
Natrunix	Active comparator	Each participant receives one single subcutaneous injection of 100 mg (Cohort 1), 200 mg (Cohort 2), or 400 mg (Cohort 3) of Natrunix. Receives: Biological: Natrunix
Placebo	Placebo comparator	Each participant receives one single subcutaneous injection of 0.5 ml (Cohort 1), 1 ml (Cohort 2), or 2 ml (Cohort 3) of Placebo. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events
Participants were monitored for treatment-emergent adverse events (TEAEs) immediately after the initial subcutaneous administration on Day 0 (Visit 1) through the final follow-up on Day 28 (Visit 7).
All identified adverse events were documented and graded for severity according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."
Measured: From Day 0 up to Day 28

Secondary outcomes (4)

Maximum Plasma Concentration (Cmax)
This outcome measure represents the peak exposure following a single subcutaneous administration of Natrunix. Cmax is assessed using a proprietary immunoassay. Placebo participants were not assessed for PK Outcome Measures
Measured: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.
Terminal Plasma Concentration
This outcome measure evaluates the circulating drug levels at the end of the study observation period. Plasma samples were analyzed using a validated proprietary immunoassay to detect and quantify concentration levels of Natrunix. Placebo participants were not assessed for PK Outcome Measures
Measured: Day 28
Half-life
Half-life is calculated by Thermo-Scientific Kinetica Version 5.1 SP1, using average observed Natrunix plasma concentration of all time points of all patients for each treatment cohort. Placebo participants were not assessed for PK Outcome Measures
Measured: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.
Area Under the Curve
This outcome measure calculates the area Under the Concentration-Time Curve (AUC) from the time of administration (Day 0) through the final observation point at Day 28. Placebo participants were not assessed for PK Outcome Measures
Measured: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 20228 Aug 2022

First posted29 Oct 2021
Study start19 Jan 2022
Primary completion8 Aug 2022
Study completion8 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies 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: Sequential
Model description: Each subject receives a single subcutaneous injection of Natrunix at one of the three doses (100 mg, 200 mg or 400 mg) and/or placebo for duration of 28 days. For each dose cohort, six subjects administer Natrunix and two subjects administer placebo. The study proceeds to the next dose level if the tested dose level have acceptable tolerability and safety. Subjects undergo blood sampling for toxicity and Pk analysis. Subjects are evaluated for the development of anti-drug antibodies (ADA).
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05099510
Sponsor's protocol ID: 2021-PT053
Status last verified: Jun 2026
First submitted: 16 Sep 2021
Last updated: 14 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No It is not yet known if there will be a plan to make IPD available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Open-label, Placebo-controlled Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Natrunix Via Subcutaneous Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT05099510
Acronym / sponsor ID: 2021-PT053
Conditions: Pharmacokinetics
Keywords: Safety, Pharmacokinetics, Dose escalation study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: XBiotech, Inc.Industry (pharma, biotech, devices)
Study start: 19 Jan 2022 (actual)
Primary completion: 8 Aug 2022 (actual)
Study completion: 8 Aug 2022 (actual)
First posted: 29 Oct 2021 (actual)
Results: Posted 14 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Title: A Phase I open-label, placebo-controlled dose escalation study to evaluate safety and pharmacokinetics of Natrunix via subcutaneous injection in healthy subjects.

Sponsor: XBiotech USA, Inc.

Study Chair: Neha Reshamwala, MD

Number of Planned Subjects: Eight healthy subjects per cohort (including six for Natrunix and two for placebo). Three cohorts for a total of 24 healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Each subject receives a single subcutaneous injection of Natrunix at one of the three doses (100 mg, 200 mg or 400 mg) and/or placebo for duration of 28 days. For each dose cohort, six subjects administer Natrunix and two subjects administer placebo. The study proceeds to the next dose level if the tested dose level have acceptable tolerability and safety. Subjects undergo blood sampling for toxicity and Pk analysis. Subjects are evaluated for the development of anti-drug antibodies (ADA).

Arm	Type	Receives
Natrunix	Active comparator	Biological: NatrunixEach participant receives one single subcutaneous injection of 100 mg (Cohort 1), 200 mg (Cohort 2), or 400 mg (Cohort 3) of Natrunix.
Placebo	Placebo comparator	Biological: PlaceboEach participant receives one single subcutaneous injection of 0.5 ml (Cohort 1), 1 ml (Cohort 2), or 2 ml (Cohort 3) of Placebo.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age: ≥ 18
Adequate bone marrow function defined as:
Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
Adequate hepatic function defined as:
serum albumin ≥ 3.0 g/dL

Key exclusion criteria (18 listed)

Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
Uncontrolled or significant cardiovascular disease, including:
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, cerebrovascular accident within three months, ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participating in the trial.

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
NatrunixThe active ingredient in the drug product Natrunix is XB2001, a recombinant human Immunoglobulin G4 monoclonal antibody specific for human interleukin-1-alpha (IL-1-alpha). The entire XB2001 heavy and light chain sequences are identical to those found in naturally-occurring humans, with the light and heavy chain variable regions being identical to those originally expressed by a peripheral blood B lymphocyte that was obtained from a healthy individual.	Biological	Natrunix
PlaceboPlacebo control for Natrunix subcutaneous injection.	Biological	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events
Time frame: From Day 0 up to Day 28
Participants were monitored for treatment-emergent adverse events (TEAEs) immediately after the initial subcutaneous administration on Day 0 (Visit 1) through the final follow-up on Day 28 (Visit 7). All identified adverse events were documented and graded for severity according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."

4 secondary outcomes

Maximum Plasma Concentration (Cmax)
Time frame: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.
Terminal Plasma Concentration
Time frame: Day 28
Half-life
Time frame: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.
Area Under the Curve
Time frame: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.

Results and safety

Results posted to the registry on 14 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Natrunix 100 mg	6	6
Cohort 1: Placebo	2	2
Cohort 2: Natrunix 200 mg	6	6
Cohort 2: Placebo	2	2
Cohort 3: Natrunix 400 mg	6	6
Cohort 3: Placebo	2	2

Primary outcome: Number of Participants With Treatment Emergent Adverse Events

Time frame: From Day 0 up to Day 28. Count of participants. Unit: Participants

Measure	Cohort 1: Natrunix 100 mg n = 6	Cohort 1: Placebo n = 2	Cohort 2: Natrunix 200 mg n = 6	Cohort 2: Placebo 1 ml n = 2	Cohort 3: Natrunix 400 mg n = 6	Cohort 3: Placebo 2 ml n = 2
Value	2	0	1	0	0	0

Population analysed: All participants who received a single subcutaneous dose of Natrunix.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 100 mg Natrunix	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 1: Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 2: 200 mg Natrunix	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cohort 2: Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 3: 400 mg Natrunix	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 3: Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No It is not yet known if there will be a plan to make IPD available

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Natrunix in people with Pharmacokinetics, run by XBiotech, Inc. at 1 site in United States.

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 14 inclusion and 18 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 14 Aug 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (time frame: From Day 0 up to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099510.

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 14 Aug 2026.