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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ATN-103

• Registration Number: NCT00916110
• Lead Sponsor: Ablynx, a Sanofi company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.5mgSC	ATN-103	ATN-103
4mgSC	ATN-103	ATN-103
10mgSC	ATN-103	ATN-103
25mgSC	ATN-103	ATN-103
25mgIV	ATN-103	ATN-103
50mgSC	ATN-103	ATN-103
100mgSC	ATN-103	ATN-103
200mgSC	ATN-103	ATN-103
200mgIV	ATN-103	ATN-103

Primary Outcome Measures

Name	Time	Method
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.	24weeks

Secondary Outcome Measures

Name	Time	Method
Antibody in blood and drug concentration in blood and urine are evaluated.	24weeks

Trial Locations

Locations (1)

Investigational Site; 🇯🇵 Toshima, Tokyo, Japan