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Natrunix Safety PK Study in Healthy Volunteers

NCT05099510 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

NatrunixTM

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.

BIOLOGICAL

Placebo

Placebo control for NatrunixTM subcutaneous injection.

Sponsors & Collaborators

  • XBiotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Neha Reshamwala, MD · BioBehavioral Research of Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2022-05-01
Completion
2022-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099510 on ClinicalTrials.gov