Title
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects
Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
Phase
Phase 1Lead Sponsor
AblynxStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HealthyIntervention/Treatment
ozoralizumab ...Study Participants
72To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
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
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.
