Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin; Drug: BMS-986090

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079480

IM142-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.

Enrollment: 130 patients

Sex: All

Ages: 18 to 45 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 male and female (of not childbearing potential), ages 18-45 years, inclusive
• BMI 18 to 32 kg/m2, inclusive

Exclusion Criteria:

• Any significant acute or chronic medical illness

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 9 patient groups

Panel 1: BMS-986090 (0.5 mg) or Placebo

Experimental group

Description:

BMS-986090 0.5 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Panel 2: BMS-986090 (3 mg) or Placebo

Experimental group

Description:

BMS-986090 3 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Panel 3: BMS-986090 (10 mg) or Placebo

Experimental group

Description:

BMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg)

Experimental group

Description:

BMS-986090 30 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And Keyhole limpet hemocyanin (KLH) 1 mg solution single intramuscular dose once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Drug: Keyhole limpet hemocyanin

Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg)

Experimental group

Description:

BMS-986090 100 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And KLH 1 mg solution single intramuscular dose once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Drug: Keyhole limpet hemocyanin

Panel 6: BMS-986090 (100 mg) or Placebo

Experimental group

Description:

BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)

Experimental group

Description:

BMS-986090 300 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once And KLH 1 mg solution single intramuscular dose once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Drug: Keyhole limpet hemocyanin

Panel 8: BMS-986090 (750 mg) or Placebo

Experimental group

Description:

BMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090

Panel 9: BMS-986090 (150 mg) or Placebo

Experimental group

Description:

BMS-986090 150 mg solution subcutaneously once weekly for 4 weeks OR Placebo matching with BMS-986090 0 mg solution subcutaneously once weekly for 4 weeks

Treatment:

Drug: Placebo matching with BMS-986090

Drug: BMS-986090