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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Placebo control for Natrunix subcutaneous injection.
BioBehavioral Research of Austin, A Telemed2U Company
Austin, Texas, United States
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."
Time frame: From Day 0 up to Day 28
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
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
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
Time frame: 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
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
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
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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.