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

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

Official Title
-----------------
Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.5mgSC<br>ATN-103 | Drug: ATN-103<br>* 1.5 mg solution, single subcutaneous injection<br>|
| Experimental: 4mgSC<br>ATN-103 | Drug: ATN-103<br>* 4 mg solution, single subcutaneous injection<br>|
| Experimental: 10mgSC<br>ATN-103 | Drug: ATN-103<br>* 10 mg solution, single subcutaneous injection<br>|
| Experimental: 25mgSC<br>ATN-103 | Drug: ATN-103<br>* 25 mg solution, single subcutaneous injection<br>|
| Experimental: 25mgIV<br>ATN-103 | Drug: ATN-103<br>* 25 mg solution, single intravenous injection<br>|
| Experimental: 50mgSC<br>ATN-103 | Drug: ATN-103<br>* 50 mg solution, single subcutaneous injection<br>|
| Experimental: 100mgSC<br>ATN-103 | Drug: ATN-103<br>* 100 mg solution, single subcutaneous injection<br>|
| Experimental: 200mgSC<br>ATN-103 | Drug: ATN-103<br>* 200 mg solution, single subcutaneous injection<br>|
| Experimental: 200mgIV<br>ATN-103 | Drug: ATN-103<br>* 200 mg solution, single intravenous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects