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

Ablynx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ATN-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT00916110

B2271002

3242K1-1001

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 9 patient groups

1.5mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

4mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

10mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

25mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

25mgIV

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

50mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

100mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

200mgSC

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

200mgIV

Experimental group

Description:

ATN-103

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103