NCT00916110

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

May 28, 2009

Last Update Submit

January 15, 2013

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.

    24weeks

Secondary Outcomes (1)

  • Antibody in blood and drug concentration in blood and urine are evaluated.

    24weeks

Study Arms (9)

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

Drug: ATN-103

200mgSC

EXPERIMENTAL

ATN-103

Drug: ATN-103

200mgIV

EXPERIMENTAL

ATN-103

Drug: ATN-103

Interventions

ATN-103DRUG

1.5 mg solution, single subcutaneous injection

1.5mgSC

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Toshima City, Tokyo, 171-0014, Japan

Location

Study Officials

  • Josefin-Beate Holz, MD

    Ablynx NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 9, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

JP(1)