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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00916110

Acronym

ATN-103

Enrollment

Registered

2009-06-09

Start date

2008-11-30

Completion date

2009-11-30

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy subjects

Brief summary

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

Interventions

DRUGATN-103

1.5 mg solution, single subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.	24weeks

Secondary

Measure	Time frame
Antibody in blood and drug concentration in blood and urine are evaluated.	24weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026