Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Severe Sepsis

Treatments: Other: Placebo; Drug: BMS-986189

Study type: Interventional

Funder types: Industry

Identifiers

NCT02739373

AI006-003

Details and patient eligibility

About

The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy, males and females, 18 to 55 years of age, inclusive
• Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
• Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug

Exclusion Criteria:

• Any significant acute or chronic medical illness
• History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder
• History of autoimmune disease
• Any known skin condition that would affect subcutaneous dosing
• Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

BMS-986189

Experimental group

Description:

Specified Dose on Specified Day

Treatment:

Drug: BMS-986189

Placebo

Placebo Comparator group

Description:

Specified Dose on Specified Day

Treatment:

Other: Placebo