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

NCT05099510 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2021-PT053
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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). Three cohorts for a total of 24 healthy volunteers.

Conditions

Pharmacokinetics

Keywords

Safety; Pharmacokinetics; Dose escalation study

Outcome Measures

Primary Outcomes (1)

• 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."

  From Day 0 up to Day 28

Secondary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  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

  Day 28

• Half-life

  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

  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.

Study Arms (2)

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.

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.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Placebo control for Natrunix subcutaneous injection.

Placebo

Natrunix BIOLOGICAL

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.

Natrunix

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• XBiotech, Inc.: lead

Study Sites (1)

BioBehavioral Research of Austin, A Telemed2U Company

Austin, Texas, 78759, United States

Location

Results Point of Contact

• Title: XBiotech Clinical
• Organization: XBiotech

clinicaltrials@xbiotech.com

1-512-386-2900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 29, 2021
• Study Start: January 19, 2022
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: August 14, 2026
• Results First Posted: August 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)