NCT02991885

HAL-MPE1 Safety and Tolerability Study

A Randomized, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Safety, Tolerability and Immunologic Effects of HAL-MPE1 Subcutaneous Immunotherapy in Adult and Paediatric Subjects With Peanut Allergy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 5 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and children with peanut allergy.

Detailed description

At the time of the study there was no effective treatment available for peanut allergy other than avoidance of peanut allergens. There was high unmet medical need for a disease modifying treatment for peanut allergy, especially for peanut allergic children, since this age group is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. The safety and tolerability of HAL-MPE1 have been established in a First-in-human (FIH) study in adults.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	HAL-MPE1	Weekly subcutaneous administrations of HAL-MPE1
DRUG	HAL-MPE1 placebo	Weekly subcutaneous administrations of HAL-MPE1 placebo

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-04-01
• Completion: 2019-09-01
• First posted: 2016-12-14
• Last updated: 2020-02-19

Locations

7 sites across 2 countries: United States, Canada