LCA-0061 dose-ranging safety study for people with allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 trial. It uses a randomized, double-blind, placebo-controlled design to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous LCA-0061 in participants with atopic conditions (SAD) and peanut allergy (MAD). Part A focuses on atopy history and elevated IgE, while Part B focuses on peanut allergy with peanut-specific IgE and skin test positivity. Participants will receive LCA-0061 or placebo and will be monitored for adverse events and immune responses. The study aims to identify safe dosage ranges and initial biological activity in these populations.

Why it matters

Who can join: the full rules

Key Inclusion Criteria: Part A (SAD) and Part B (MAD)

1. Must provide written consent for participation
2. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening
3. Have elevated serum IgE at screening
4. Female participants of childbearing potential or male participants capable of fathering a child must be willing to use highly effective methods of contraception throughout the study and for at least 30 days after the last dose of the investigational product.

Part A Only

1.Must be otherwise healthy with history of atopy defined as one or more of the following: history of positive skin tests to common allergens, allergic conjunctivitis, food allergy, atopic dermatitis, urticaria

Part B Only

1. Be otherwise healthy with history of peanut allergy
2. Elevated peanut-specific serum IgE within 6 months of screening
3. Have positive skin prick test (SPT) to peanuts at screening

Key Exclusion Criteria: Part A and B

1. Pregnant or lactating
2. History of clinically relevant underlying comorbidities including:

   1. chronic obstructive pulmonary disease
   2. myocardial infarction
   3. chronic heart failure or unstable angina pectoris
   4. hyperlipidemia
   5. liver disease or known hepatic or biliary abnormalities \[except Gilbert's disease or asymptomatic gallstones\]
   6. autoimmune or connective tissue disease
   7. chronic inflammatory disease
   8. persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals
   9. poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators
   10. Poorly controlled asthma
   11. poorly controlled hypertension
3. clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening
4. Currently receiving immunotherapy for food allergies
5. Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening.
6. Positive test for alcohol or illicit drugs at screening or prior to dosing.
7. Other conditions or concomitant medications that are excluded by the protocol, or in the opinion of the investigator, or sponsor representative, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Where it's running

• Can001
  Mississauga, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Head of Clinical Operations
• Email: LCA-0061studyinquiry@lyciatx.com
• Phone: 650-392-3357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.