Healthy Adults
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.
Detailed description
Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96 Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)
Interventions
DRUGBMS-986089
DRUGPlacebo matching with BMS-986089
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations * Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years * Women must not be breastfeeding * Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year
Exclusion criteria
* Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration * Any condition that will clearly require medical or surgical treatment during the period of study participation * Any bone trauma or bone surgery within 3 months of study drug administration * Known or suspected autoimmune disorder * Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations | Single Ascending Dose (SAD) Phase 119 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed serum concentration (Tmax) for SAD and MAD | SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 |
| Serum concentration 168 h post dose (C(168H)) for SAD and MAD | SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD | SAD phase: Day1 to Day 91 |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD | SAD phase: Day1 to Day 91 |
| Apparent total body clearance (CLT/F) for SAD | SAD phase: Day1 to Day 91 |
| Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD | SAD phase: Day1 to Day 91 |
| Half life (T-Half) for SAD and MAD | SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 |
| Serum concentration 336 h post dose (C(336H)) for SAD and MAD | SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 |
| Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD | MAD phase: Day 1 to Day 120 |
| Maximum observed serum concentration (Cmax) for SAD and MAD | SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 |
| Degree of Fluctuation or Fluctuation Index (DF) for MAD | MAD phase: Day 1 to Day 120 |
| Average concentration over a dosing interval (Css-Avg) for MAD | MAD phase: Day 1 to Day 120 |
| AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD | MAD phase: Day 1 to Day 120 |
| Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD | MAD phase: Day 1 to Day 120 |
| C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD | MAD phase: Day 1 to Day 120 |
| C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD | MAD phase: Day 1 to Day 120 |
| Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD | 30 days |
| The pharmacodynamic effect of single and multiple doses of BMS-986089 on free myostatin, total myostatin (pre-dose only), and myostatin-drug complex will be assessed by measuring these biomarkers for SAD and MAD | 30 days |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD | MAD phase: Day 1 to Day 120 |
Countries
United States
Outcome results
None listed