None listed
Conditions
Brief summary
The purpose of this study is to assess the bioavailability, safety and tolerability of study drug BMS-929075 using blood samples and safety assessments following either a SC injection compared to IV administration of BMS- in healthy subjects.
Interventions
22 Healthy subjects will be assigned to one of the below treatment arms -
Treatment A (N=6): Open-label intravenous (IV), 90 mg/mL x 2.4 mL (total 216 mg/ 50 mL normal saline).
Treatment B (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/mL x 2 injections (1.2 mL per injection / total 216 mg per subject) or placebo administered at one location, 2 adjunct injections in one anterior upper thigh.
Treatment C (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/
22 Healthy subjects will be assigned to one of the below treatment arms - Treatment A (N=6): Open-label intravenous (IV), 90 mg/mL x 2.4 mL (total 216 mg/ 50 mL normal saline). Treatment B (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/mL x 2 injections (1.2 mL per injection / total 216 mg per subject) or placebo administered at one location, 2 adjunct injections in one anterior upper thigh. Treatment C (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/mL x 4 injections (1.2 mL per injection / total 432 mg per subject) or placebo administered at 2 locations, 2 adjunct injections in each anterior upper thigh. Subjects will be randomized to Treatment A (active), Treatment B (active), Treatment B (placebo), Treatment C (active) or Treatment C (placebo) in a ratio of 3:3:1:3:1. Randomizations will be stratified within each group equally to either the 60- < 80 kg weight group or the 80-100 kg weight group .
Sponsors
Bristol-Myers Squibb
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female subjects, ages 18-55 years inclusive, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations, will be eligible to participate in the study. All subjects must weigh between 60-100 kg, inclusive. Subjects within each treatment group will be weight matched between the 60 - < 80 kg and the 80 - 100 kg weight groups. All subjects must have a negative QuantiFERON-TB Gold test (QFT-G) at screening
Exclusion criteria
Active TB requiring treatment within the previous 3 years. Any significant acute or chronic medical illness, including any: -bacterial infections within previous 12 weeks -HIV, Hep B or Hep C - gastrointestinal disease within the past 3 months -autoimmuine disorders Any major surgery, donation of blood or plasma to a blood bank or receipt of a blood transfusion within the past 4 weeks. Smoking more than 10 cigarettes per day. Healthy subjects with any of the following ECG findings prior to dosing: - PR>/= 210 msec - QRS>/= 120 msec - QT>/= 500 msec - QTcF>/+ 450 msec Positive urine screen for drugs of abuse or positive screen for Hepatitis C, Hepatitis B or HIV.
Outcome results
None listed