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

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ClinicalTrials.gov Identifier: NCT00916110
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
Ablynx

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ATN-103 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: 1.5mgSC
ATN-103
Drug: ATN-103
1.5 mg solution, single subcutaneous injection

Experimental: 4mgSC
ATN-103
Drug: ATN-103
4 mg solution, single subcutaneous injection

Experimental: 10mgSC
ATN-103
Drug: ATN-103
10 mg solution, single subcutaneous injection

Experimental: 25mgSC
ATN-103
Drug: ATN-103
25 mg solution, single subcutaneous injection

Experimental: 25mgIV
ATN-103
Drug: ATN-103
25 mg solution, single intravenous injection

Experimental: 50mgSC
ATN-103
Drug: ATN-103
50 mg solution, single subcutaneous injection

Experimental: 100mgSC
ATN-103
Drug: ATN-103
100 mg solution, single subcutaneous injection

Experimental: 200mgSC
ATN-103
Drug: ATN-103
200 mg solution, single subcutaneous injection

Experimental: 200mgIV
ATN-103
Drug: ATN-103
200 mg solution, single intravenous injection




Primary Outcome Measures :
  1. Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc. [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Antibody in blood and drug concentration in blood and urine are evaluated. [ Time Frame: 24weeks ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 26.4.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916110


Locations
Japan
Investigational Site
Toshima, Tokyo, Japan, 171-0014
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz, MD Ablynx NV

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT00916110     History of Changes
Other Study ID Numbers: 3242K1-1001
B2271002
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Ablynx:
healthy subjects