DSP-3025 A Phase 1 Study of Healthy Male Volunteers | NCT01124396

Studies
DSP-3025 A Phase 1 Study of Healthy Male Volunteers

NCT01124396

Sponsor

Sumitomo Pharma Co., Ltd.

Status

Completed

Last Update Posted

Apr 12, 2022Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Healthy

Interventions

DSP-3025
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Apr 2012Actual

First Submitted Date

May 13, 2010

First Submission Date that Met QC Criteria

May 13, 2010

First Posted Date

May 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2022

Last Update Posted Date

Apr 12, 2022Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
30 ug	30 ug	Drug: DSP-3025
60 ug	60 ug	Drug: Placebo
Placebo	Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSP-3025	Drug		30 ug
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry		During the study

Secondary Outcomes

Measure	Description	Time Frame
Clinical chemistry, haematology, urinalysis, autoantibodies		During the study
Nasal symptoms and peak nasal inspiratory flow		During the study
Pharmacokinetics

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kitasato University East Hospital		Asamizodai 2-1-1, Minami-ku, Sagamihara	Kanagawa	252-0380	Japan