RecruitingPhase 1Phase 2NCT07349212

UKK-0018 is an Immunotherapeutic for Treatment of Peanut Allergies

A First-in-Human, Ascending Dose, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UKK-0018 in Peanut Allergic Individuals


Sponsor

Ukko Inc

Enrollment

40 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test a new investigational treatment called UKK-0018. UKK-0018 is an immunotherapeutic for the treatment of peanut allergies. The treatment is given by injection and is designed to train the immune system to tolerate peanut exposure over time.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

  • Adults 18-55 years old
  • documented history of physician-diagnosed peanut allergy
  • positive skin prick test (SPT)
  • screening DBPCFC peanut protein
  • contraception use should be consistent with local regulations
  • capable of providing signed written informed consent

Exclusion Criteria10

  • asthma based on NHLBI
  • uncontrolled cardiovascular disease
  • chronic disease history
  • exacerbation of dermatological conditions
  • life threatening episodes of anaphylaxis
  • active infections
  • poor physical or blood chemistry
  • immunodeficiency, bleeding disorders, malignancies
  • hypersensitivities to epinephrine, inactive ingredients in therapy
  • pregnant or breast feeding

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Interventions

BIOLOGICALUKK-0018

UKK0018 is an immunotherapeutic treatment of peanut allergies


Locations(5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Flinders Medical Center

Bedford Park, South Australia, Australia

The Royal Melbourne Hospital

Fitzroy, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Pacific Clinical Research Network - Auckland

Takapuna, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07349212