Phase 1 Study to Assess Safety and Effects of LCA-0061 in Adults with Atopic Conditions and Peanut Allergy

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study LCA-0061, an antibody-based drug designed to target and clear immunoglobulin E IgE, in adults with atopic conditions and peanut allergy. The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending subcutaneous doses of LCA-0061 compared to placebo. This trial includes participants with a history of atopy or peanut allergy to better understand the drugs effects in these populations. Participants are divided into cohorts receiving either single ascending doses SAD or multiple ascending doses MAD of LCA-0061 or placebo. The single dose groups include cohorts 1 to 5, while multiple dose groups include cohorts 1 to 4. The study is randomized and double-blind, ensuring participants and researchers do not know who receives the drug or placebo. Doses are administered subcutaneously according to the cohort assignment. Throughout the trial, participants will be monitored closely for treatment-emergent adverse events, laboratory abnormalities, vital signs, and electrocardiograms for up to 36 days in the single dose portion and up to 93 days in the multiple dose portion. Pharmacokinetic parameters such as drug concentration peaks and half-life will also be assessed. The study requires written consent, adherence to contraception guidelines, and involves regular evaluations to measure safety and drug effects during the treatment periods.

Single Ascending and Multiple Ascending Dose Study of LCA-0061