DSP-3025 A Phase 1 Study of Healthy Male Volunteers

Sumitomo Pharma

Status: Completed

Conditions: Healthy

Treatments: Drug: Placebo; Drug: DSP-3025

Study type: Observational

Funder types: Industry

Identifiers

NCT01124396

D7002027

Details and patient eligibility

About

Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers

Enrollment: 24 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

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 respiratory disorder(s) such as asthma

Trial design

24 participants in 3 patient groups

30 ug

Description:

30 ug

Treatment:

Drug: DSP-3025

60 ug

Description:

60 ug

Treatment:

Drug: Placebo

Placebo

Description:

Placebo