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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT00916110
First received: May 28, 2009
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

May 28, 2009
January 15, 2013
November 2008
November 2009   (final data collection date for primary outcome measure)
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc. [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00916110 on ClinicalTrials.gov Archive Site
Antibody in blood and drug concentration in blood and urine are evaluated. [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: ATN-103
    1.5 mg solution, single subcutaneous injection
  • Drug: ATN-103
    4 mg solution, single subcutaneous injection
  • Drug: ATN-103
    10 mg solution, single subcutaneous injection
  • Drug: ATN-103
    25 mg solution, single subcutaneous injection
  • Drug: ATN-103
    25 mg solution, single intravenous injection
  • Drug: ATN-103
    50 mg solution, single subcutaneous injection
  • Drug: ATN-103
    100 mg solution, single subcutaneous injection
  • Drug: ATN-103
    200 mg solution, single subcutaneous injection
  • Drug: ATN-103
    200 mg solution, single intravenous injection
  • Experimental: 1.5mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 4mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 10mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 25mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 25mgIV
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 50mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 100mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 200mgSC
    ATN-103
    Intervention: Drug: ATN-103
  • Experimental: 200mgIV
    ATN-103
    Intervention: Drug: ATN-103
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00916110
3242K1-1001, B2271002
No
Ablynx
Ablynx
Not Provided
Study Director: Josefin-Beate Holz, MD Ablynx NV
Ablynx
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP