Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season (SAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy; Allergic Rhinitis

Treatments: Drug: AZD8848; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688779

D0540C00001

Details and patient eligibility

About

Investigate safety/tolerability after a single dose intranasal administration of AZD8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season

Enrollment: 130 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• History of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years
• Body mass index (BMI) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg
• No clinically relevant abnormal findings

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD8848

2

Placebo Comparator group

Treatment:

Drug: Placebo