NCT02469688

A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy

A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy

Detailed description

This study consists of 2 parts: Part 1 and Part 2. \[Part 1\] An open-label, un-controlled study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4 times) and the ASP4070 intradermal vaccination group (high dose x 4 times). \[Part 2\] A placebo-controlled, double-blinded, randomized, parallel-group comparative study Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group (high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group (low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared to those for the placebo group. The study will be double-blinded within the same route of vaccination, and non-blinded between the routes of vaccination (between the intramuscular vaccination group and intradermal vaccination group). The first vaccination to the subjects in Part 2 will start at least 14 days after the first vaccination to the subjects in Part 1 (6 subjects). For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose of the study drug at Day 43 (until Day 127). After the primary study period, safety information will be collected for 9 months (for 1 year from the last dose of the study drug) as the long-term safety follow-up study period. Safety information will be collected for 1 year starting from the last vaccination of the study drug also from the patients who discontinued the participation in the study during the primary study period if the patients agree.

Conditions

• Cedar Pollinosis

Interventions

Type	Name	Description
DRUG	ASP4070	intramuscular or intradermal
DRUG	Placebo	intramuscular or intradermal

Timeline

• Start date: 2015-06-18
• Primary completion: 2015-11-27
• Completion: 2016-07-26
• First posted: 2015-06-11
• Last updated: 2024-10-31

Locations

1 site across 1 country: Japan