DSP-3025 A Phase 1 Study of Healthy Male Volunteers

NCT ID: NCT01124396

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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30 ug

30 ug

DSP-3025

Intervention Type DRUG

60 ug

60 ug

Placebo

Intervention Type DRUG

Placebo

Placebo

No interventions assigned to this group

Interventions

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DSP-3025

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kitasato University East Hospital

Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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D7002027

Identifier Type: -

Identifier Source: org_study_id

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