NCT00916110
Completed
Phase 1
Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
Ablynx, a Sanofi company1 site in 1 country72 target enrollmentNovember 2008
Overview
- Phase
- Phase 1
- Intervention
- ATN-103
- Conditions
- Healthy
- Sponsor
- Ablynx, a Sanofi company
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
Investigators
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.
- •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.
Arms & Interventions
1.5mgSC
ATN-103
Intervention: ATN-103
4mgSC
ATN-103
Intervention: ATN-103
10mgSC
ATN-103
Intervention: ATN-103
25mgSC
ATN-103
Intervention: ATN-103
25mgIV
ATN-103
Intervention: ATN-103
50mgSC
ATN-103
Intervention: ATN-103
100mgSC
ATN-103
Intervention: ATN-103
200mgSC
ATN-103
Intervention: ATN-103
200mgIV
ATN-103
Intervention: ATN-103
Outcomes
Primary Outcomes
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
Time Frame: 24weeks
Secondary Outcomes
- Antibody in blood and drug concentration in blood and urine are evaluated.(24weeks)
Study Sites (1)
Loading locations...
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