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

January 15, 2013 updated by: Ablynx

Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects

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

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Tokyo
  - Toshima, Tokyo, Japan, 171-0014
    - Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1.5mgSC ATN-103	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
EXPERIMENTAL: 4mgSC ATN-103	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
EXPERIMENTAL: 10mgSC ATN-103	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
EXPERIMENTAL: 25mgSC ATN-103	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
EXPERIMENTAL: 25mgIV ATN-103	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
EXPERIMENTAL: 50mgSC ATN-103	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
EXPERIMENTAL: 100mgSC ATN-103	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
EXPERIMENTAL: 200mgSC ATN-103	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
EXPERIMENTAL: 200mgIV ATN-103	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody in blood and drug concentration in blood and urine are evaluated. Time Frame: 24weeks	24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (ESTIMATE)

June 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

healthy subjects

Other Study ID Numbers

3242K1-1001
B2271002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Prevent Age Resort "Pervaya Liniya"

Recruiting

First Line Prevent Age Study (FLIPS)

Healthy Aging | Healthy Diet | Healthy Lifestyle

Russian Federation
Maastricht University Medical Center

Completed

Reference Gait Data for Healthy Subjects

Healthy Volunteers | Healthy Subjects | Healthy Adults

Netherlands
Yale University

Not yet recruiting

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

Healthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol

United States
Hasselt University

Recruiting

Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults

Healthy | Healthy Aging

Belgium
Galera Therapeutics, Inc.
Syneos Health

Completed

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
Galera Therapeutics, Inc.
Syneos Health

Completed

A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
University of Pennsylvania

Active, not recruiting

The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions

Healthy | Healthy Aging

United States
Chalmers University of Technology
Göteborg University

Completed

Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein

Healthy | Nutrition, Healthy

Sweden
Lancaster University

Recruiting

Speed of Absorption

Healthy | Nutrition, Healthy

United Kingdom
University of Manitoba

Not yet recruiting

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

Healthy | Healthy Diet

Clinical Trials on ATN-103

Ablynx

Completed

Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

United States, Russian Federation, Canada, Hungary, Japan, Serbia, South Africa, Switzerland
Ablynx

Completed

Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Japan
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse... and other collaborators

Completed

Immunologic Memory (Supp. of ATN 024)

HIV Infections

United States
DePuy Orthopaedics

Completed

DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial (ATN)

Femoral Fracture (Proximal)

United States
Attenuon

Terminated

ATN-161 in Advanced Renal Cell Cancer

Carcinoma, Renal Cell

United States
InQpharm Group

Completed

Benefit and Tolerability of IQP-AE-103 in Weight Loss

Obesity | Overweight

Germany
CellabMED

Recruiting

A Clinical Study of IL13Rα2 Targeted CAR-T in Patients With Malignant Glioma (MAGIC-I)

Recurrent Malignant Glioma

Korea, Republic of
Takeda

Active, not recruiting

A Study of TAK-103 in Adult With Solid Tumors

Solid Tumors

Japan
Peptomyc S.L.

Terminated

Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (MYCure)

Pancreatic Cancer | Advanced Solid Tumors | CRC

Spain
Fondazione Telethon
Ospedale San Raffaele

Active, not recruiting

A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With Wiskott-Aldrich Syndrome

Wiskott-Aldrich Syndrome

Italy, United States

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

Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on ATN-103

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations