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

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis; Healthy Volunteer

Treatments: Drug: Placebo; Drug: DSP-3025

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925678

D7002013

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DSP-3025

2

Placebo Comparator group

Treatment:

Drug: Placebo