DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg

• No clinically relevant abnormal findings

• History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)

Exclusion Criteria:

• Acute illness which requires medical intervention

• Definite or suspected personal history of adverse drug reactions or drug hypersensitivity

• Clinical relevant disease or disorder (past or present)

• A history of asthma