A randomized, double-blinded, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BMS-986259 in healthy participants

Completed

• Conditions: Heart failure; 10019280

• Registration Number: NL-OMON49614
• Lead Sponsor: BritsolMyers Squibb Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-12-16
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 82

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Incidence of AEs, SAEs, and AEs leading to discontinuation.<br /><br>- Results of vital signs, ECGs, physical examinations, and clinical laboratory<br /><br>tests.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- SAD: Cmax, Tmax, kel, T-HALF, AUC(0-T), AUC(INF), CL/F, and Vz/F.<br /><br>- MAD:<br /><br>* Day 1: Cmax, Tmax, AUC(TAU).<br /><br>* Day 13: Cmax, Tmax<br /><br>* Day 14: Cmax, Tmax, AUC(0-T), AUC(TAU), kel, T-HALF, CL/F, Vz/F, AR(Cmax),<br /><br>AR(AUC[TAU]).<br /><br>- NAb and ADAs</p><br>