Natrunix Safety PK Study in Healthy Volunteers

NCT05099510 | Unknown Phase 1 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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with treatment related adverse events assessed according to CTCAE v5.0

  Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v4.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.

  28 days

Secondary Outcomes (4)

• Maximum plasma concentration of test article 2) Terminal plasma concentration 3) Plasma half-life 4) Total exposure

  28 days

• Terminal plasma concentration

  28 days

• Half-life

  28 days

• Total exposure

  28 days

Study Arms (2)

NatrunixTM

ACTIVE COMPARATOR

Each participant will receive one single subcutaneous injection of 200 mg (Cohort 1), 400 mg (Cohort 2), or 800 mg (Cohort 3) of NatrunixTM.

Biological: NatrunixTM

Placebo

PLACEBO COMPARATOR

Each participant will receive one single subcutaneous injection of placebo.

Biological: Placebo

Interventions

NatrunixTM BIOLOGICAL

The active ingredient in the drug product NatrunixTM is XB2001, a recombinant human IgG4 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 human IgG4-kappa, 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.

NatrunixTM

Placebo BIOLOGICAL

Placebo control for NatrunixTM subcutaneous injection.

Placebo

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

RECRUITING

Study Officials

• Neha Reshamwala, MD

  BioBehavioral Research of Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haritha Pallapotu, MS

CONTACT

512-386-2992; hpallapotu@xbiotech.com

Norma Gonzalez

CONTACT

512-386-2903; ngonzalez@xbiotech.com

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 will receive a single subcutaneous injection of Natrunix at one of the three doses (200 mg, 400 mg or 800 mg) or placebo. For each dose cohort, six subjects will be administered Natrunix and two subjects will be administered placebo. The study will not proceed to the next dose level unless the tested dose level has been deemed to have acceptable tolerability and safety. Subjects will undergo blood sampling for toxicity and pK analysis. Subjects will also be 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: May 1, 2022
• Study Completion: June 15, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)