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

NCT00916110 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-01-16

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

ATN-103

1.5 mg solution, single subcutaneous injection

DRUG

ATN-103

4 mg solution, single subcutaneous injection

DRUG

ATN-103

10 mg solution, single subcutaneous injection

DRUG

ATN-103

25 mg solution, single subcutaneous injection

DRUG

ATN-103

25 mg solution, single intravenous injection

DRUG

ATN-103

50 mg solution, single subcutaneous injection

DRUG

ATN-103

100 mg solution, single subcutaneous injection

DRUG

ATN-103

200 mg solution, single subcutaneous injection

DRUG

ATN-103

200 mg solution, single intravenous injection

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Josefin-Beate Holz, MD · Ablynx NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00916110 on ClinicalTrials.gov