Trials / Completed
CompletedNCT02163018
HAL-MPE1 First-in-human
A First-in-human, Randomized, Double Blind, Placebo Controlled, Single-centre Study to Assess the Safety and Tolerability of HAL-MPE1 in Patients With Peanut Allergy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- HAL Allergy · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. Results from in vitro and in vivo preclinical studies demonstrate the immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HAL-MPE1 | Subcutaneous administration of increasing doses of HAL-MPE1 |
| DRUG | Placebo | Subcutaneous administration of increasing doses of placebo |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-05-01
- Completion
- 2015-06-01
- First posted
- 2014-06-13
- Last updated
- 2015-07-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02163018. Inclusion in this directory is not an endorsement.