Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects (ATN-103)
January 15, 2013 updated by: Ablynx
Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Toshima, Tokyo, Japan, 171-0014
- Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1.5mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 4mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 10mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 25mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 25mgIV
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 50mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 100mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 200mgSC
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
|
EXPERIMENTAL: 200mgIV
ATN-103
|
1.5 mg solution, single subcutaneous injection
4 mg solution, single subcutaneous injection
10 mg solution, single subcutaneous injection
25 mg solution, single subcutaneous injection
25 mg solution, single intravenous injection
50 mg solution, single subcutaneous injection
100 mg solution, single subcutaneous injection
200 mg solution, single subcutaneous injection
200 mg solution, single intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
Time Frame: 24weeks
|
24weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Antibody in blood and drug concentration in blood and urine are evaluated.
Time Frame: 24weeks
|
24weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
November 1, 2009
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
June 8, 2009
First Posted (ESTIMATE)
June 9, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3242K1-1001
- B2271002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.