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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: ATN-103
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc. [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody in blood and drug concentration in blood and urine are evaluated. [ Time Frame: 24weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916110

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

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT00916110     History of Changes
Other Study ID Numbers: 3242K1-1001, B2271002
Study First Received: May 28, 2009
Last Updated: January 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Ablynx:
healthy subjects

ClinicalTrials.gov processed this record on April 15, 2014