Healthy Adult Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests | Up to Day 85 after single dose of BMS-986090 | AE = Adverse event ECG = Electrocardiogram |
| Safety and tolerability of multiple dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests | Up to Day 106 after multiple dose of BMS-986090 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV | Days 1 -85 |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of single dose BMS-986090 SC and IV | Days 1 -85 |
| Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV | Days 1 -85 |
| Total body clearance (CLT) of single dose BMS-986090 IV | Days 1 -85 |
| Apparent total body clearance (CLT/F) of single dose BMS-986090 SC | Days 1 -85 |
| Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV | Days 1 -85 |
| Volume of distribution during steady state (Vss) of single dose BMS-986090 IV | Days 1 -85 |
| Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC | Days 1 -85 |
| Absolute bioavailability (F) of single dose BMS-986090 SC | Days 1 -85 |
| Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC | Days 1 -106 |
| Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC | Days 1 -106 |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV | Days 1 -85 |
| Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC | Days 1 -106 |
| Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC | Days 1 -106 |
| Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC | Days 1 -106 |
| Degree of Fluctuation (DF) of multiple dose BMS-986090 SC | Days 1 -106 |
| AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986090 SC (multiple dose) | Days 1 -106 |
| Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose) | Days 1 -106 |
| Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC | Days 1 -106 |
| Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC | Days 1 -85 |
| Immunogenicity of BMS-986090 following single SC / IV infusion measured by frequency of subjects with positive anti-drug-antibody (ADA) assessment and frequency of subjects who develop positive ADA following a negative baseline | Days 1 -85 |
| Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion | Days 1 -85 |
| Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC | Days 1 -106 |
| Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV) | Days 1 -85 |
Countries
United States
Outcome results
None listed