A Phase 1, Partially Blinded, Placebo-Controlled, Pharmacokinetic Study of Intravenously Administered BMS-943539-01-001 in Healthy Male Volunteers

Phase 1

• Conditions: Pharmacokinetics of Intravenously Administered BMS-943539 in Healthy Male Volunteers. BMS-943539 is an Adnectin (protein) which is specifically engineered to bind to Human Serum Albumin (HSA).; Pharmacokinetics of Intravenously Administered BMS-943539 in Healthy Male Volunteers.; BMS-943539 is an Adnectin (protein) which is specifically engineered to bind to Human Serum Albumin (HSA).; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12610001043022
• Lead Sponsor: Bristol-Myers Squibb Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 37

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
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
dose.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified