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Completed

NCT Number: NCT00916110

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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Toshima City, Tokyo, 171-0014, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATN-103

Drug

1.5 mg solution, single subcutaneous injection

Primary outcomes

  1. Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.

    Time frame: 24weeks

Secondary outcomes

  1. Antibody in blood and drug concentration in blood and urine are evaluated.

    Time frame: 24weeks

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

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

Acronym: ATN-103

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 9, 2009
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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