ACTRN12610001043022
Not yet recruiting
Phase 1
A Phase 1, Partially Blinded, Placebo-Controlled, study of Intravenously Administered BMS-943539 to assess the pharmacokinetics and in particular the mean T-HALF of BMS-943539 across all doses in healthy male subjects.
Bristol-Myers Squibb Australia0 sites37 target enrollmentNovember 29, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb Australia
- Enrollment
- 37
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed Written Informed Consent
- •a) The signed informed consent form.
- •2\) Target Population
- •a) Healthy subjects as determined by no clinically significant deviation from normal
- •in medical history, physical examination, vital signs, electrocardiograms (ECGs),
- •and clinical laboratory determinations.
- •b) Not using prescription (including topical skin preparations other than nonprescription
- •moisturizers) or over\-the\-counter medications; herbal supplements;
- •or drugs of abuse, including alcohol and tobacco, for the duration of participation
- •in the study (screening duration plus 56 days following first administration of
Exclusion Criteria
- •1\) Target Disease Exceptions
- •a) Chronic medical conditions requiring ongoing professional medical attention or treatment.
- •2\) Medical History and Concurrent Diseases
- •a) Any history of autoimmune disease.
- •b) Recent (within 6 months) drug or alcohol abuse as defined by DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse
- •c) Use of nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within 6 months prior to investigational product administration and during the study;
- •d) Major surgery within 6 months of treatment Day 1\.
- •e) Concurrent or use within 12 months of treatment day 1 of corticosteroids or other immunosuppressant drugs, with the exception of inhaled or topical corticosteroids, for which there must be no concurrent use or use within 3 months of treatment day 1\.
- •f) Use of prescription medication within 7 days or 5 x the elimination T\-HALF, whichever is longer, before treatment Day 1\.
- •g) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration.
Outcomes
Primary Outcomes
Not specified
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