Heart failure
Conditions
Interventions
Part A:
BMS-986259 or placebo will be given as an injection under the skin
(subcutaneous) of the belly. The number of injections may count up to 6 per
dosing, depending on the dose level.
Whether
Sponsors
BritsolMyers Squibb Research and Development
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy males and females not of childbearing potential, aged 18 to 54 years at time of consent, inclusive. - Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening.
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in an investigational drug study within 2 months prior to (the first) drug administration in the current study, or 4 months prior to (the first) drug administration in case of exposure to long-acting biological investigational drug. Participation in more than 4 other drug studies in the year prior to (the first) drug administration in the current study. Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male participants)/more than 1.0 liter of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of AEs, SAEs, and AEs leading to discontinuation. - Results of vital signs, ECGs, physical examinations, and clinical laboratory tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| - SAD: Cmax, Tmax, kel, T-HALF, AUC(0-T), AUC(INF), CL/F, and Vz/F. - MAD: * Day 1: Cmax, Tmax, AUC(TAU). * Day 13: Cmax, Tmax * Day 14: Cmax, Tmax, AUC(0-T), AUC(TAU), kel, T-HALF, CL/F, Vz/F, AR(Cmax), AR(AUC[TAU]). - NAb and ADAs | — |
Countries
Netherlands
Outcome results
None listed