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 个研究点目标入组 37 人开始时间: 2010年11月29日最近更新: 2020年1月13日

试验速览

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•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
•blinded study treatment). (See also related exclusion criteria 2b, 2c, and 2f.)
•c) Agree not to donate blood or plasma to any blood bank or for any purpose (other
•than this study) for the duration of participation in the study (screening duration
•plus 56 days following first administration of blinded study treatment). (See also
•related exclusion criterion 2g.)
•d) Body Mass Index (BMI) of 18 to 32 kg/m2 (BMI=weight (kg)/[height(m)]2) and
•weight no less than 50 kg.
•3) Age and Reproductive Status
•a) Men, aged 18 to 60 years.
•b) Subjects who are sexually active must agree to use a barrier method of
•contraception during the study and for no less than 45 days following the last

•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.
•h) Blood transfusion within 4 weeks of study drug administration.

发起方

Bristol-Myers Squibb Australia