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

Healthy Clinical Trial

— ATN-103  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916110
• Other study ID #: 3242K1-1001
• Secondary ID: B2271002
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2009
• Last updated: January 15, 2013
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ATN-103
1.5 mg solution, single subcutaneous injection
• ATN-103
4 mg solution, single subcutaneous injection
• ATN-103
10 mg solution, single subcutaneous injection
• ATN-103
25 mg solution, single subcutaneous injection
• ATN-103
25 mg solution, single intravenous injection
• ATN-103
50 mg solution, single subcutaneous injection
• ATN-103
100 mg solution, single subcutaneous injection
• ATN-103
200 mg solution, single subcutaneous injection
• ATN-103
200 mg solution, single intravenous injection

Locations

Country	Name	City	State
Japan	Investigational Site	Toshima	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.		24weeks	Yes
Secondary	Antibody in blood and drug concentration in blood and urine are evaluated.		24weeks	No