72 Participants NeededMy employer runs this trial

LCA-0061 for Peanut Allergy

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Overseen ByHead of Clinical Operations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Lycia Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 1combined single ascending dose (SAD)/multiple ascending dose (MAD) randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending subcutaneous doses of LCA-0061in participants with atopic conditions (SAD) and participants with peanut allergy (MAD).

Who Is on the Research Team?

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Nadia Tchao, MD

Principal Investigator

Lycia Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for people with atopic conditions (like allergies, asthma, or eczema) and those with peanut allergy. Participants must generally be in good health aside from their allergic condition.

Inclusion Criteria

Part A and B: Have elevated serum IgE at screening
Part B Only: Be otherwise healthy with history of peanut allergy
Part A and B: Must provide written consent for participation
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Exclusion Criteria

Part A and B: Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening
Part A and B: Positive test for alcohol or illicit drugs at screening or prior to dosing
I am currently getting immunotherapy for my food allergies.
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What Are the Treatments Tested in This Trial?

Interventions

  • LCA-0061

Trial Overview

The study is testing different single and multiple doses of a new drug called LCA-0061 given as an injection under the skin, compared to a placebo. The main goal is to see if it's safe and how the body reacts to it.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B - LCA-0061 (MAD)Experimental Treatment1 Intervention
Group II: Part A - LCA-0061 (SAD)Experimental Treatment1 Intervention
Group III: Part B (MAD)Placebo Group1 Intervention
Group IV: Part A (SAD)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lycia Therapeutics, Inc.

Lead Sponsor