Study Of Single Dose Of ATN-103 Administered To Healthy J... | NCT00916110

Studies
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects

NCT00916110

Sponsor

Ablynx, a Sanofi company

Status

Completed

Last Update Posted

Jan 16, 2013Estimated

Enrollment

72Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ATN-103
ATN-103
ATN-103
ATN-103
ATN-103
ATN-103
ATN-103
ATN-103
ATN-103

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

ID	Type	Description	Link
B2271002

Status Module

Record Verification Date

Jan 2013

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

Nov 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

Jun 8, 2009

First Posted Date

Jun 9, 2009Estimated

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

Jan 15, 2013

Last Update Posted Date

Jan 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1.5mgSC	Experimental	ATN-103	Drug: ATN-103
4mgSC	Experimental	ATN-103	Drug: ATN-103
10mgSC	Experimental	ATN-103	Drug: ATN-103
25mgSC	Experimental	ATN-103	Drug: ATN-103
25mgIV	Experimental	ATN-103	Drug: ATN-103
50mgSC	Experimental	ATN-103	Drug: ATN-103
100mgSC	Experimental	ATN-103

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATN-103	Drug	1.5 mg solution, single subcutaneous injection	1.5mgSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.		24weeks

Secondary Outcomes

Measure	Description	Time Frame
Antibody in blood and drug concentration in blood and urine are evaluated.		24weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
BMI in the range of 17.6 to 26.4.
Nonsmoker or male who smokes fewer than 10 cigarettes per day.

Exclusion Criteria:

Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josefin-Beate Holz, MD	Ablynx NV	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Toshima City	Tokyo	171-0014	Japan