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

Phase 1CompletedNCT00916110

Ablynx, a Sanofi company72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

ATN-103DRUG

1.5 mg solution, single subcutaneous injection

ATN-103DRUG

4 mg solution, single subcutaneous injection

ATN-103DRUG

10 mg solution, single subcutaneous injection

ATN-103

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Investigational Site

Toshima City, Tokyo, Japan

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.

Time frame: 24weeks

Data from ClinicalTrials.gov

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