UKK-0018 as 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

This study will test a new investigational treatment called UKK-0018. UKK-0018 as 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.

The study will assess how safe and well tolerated UKK-0018 is in people with known peanut allergy, and whether it can reduce the risk of allergic symptoms following exposure to peanut proteins.

This is a first-in-human, open-label, multicenter study that will be conducted in adult participants with peanut allergy evaluating dose levels and regimens. It is anticipated that UKK-0018 can help retrain the immune system over time to respond safely to peanut proteins in case of accidental exposures. The modifications which reduce binding to IgE antibodies are anticipated to reduce risk of serious allergic reactions compared to standard of care.

Based on emerging data an optional dose expansion cohort may be added. An optional dose expansion cohort may be added if supported by emerging data. The study is comprised of a screening period, intervention period, and follow-up period.

Inclusion Criteria:

• 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 Criteria:

• 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