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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014