Clinical trial NCT04736134: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986326
Healthy participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.


Eligibility criteria: Inclusion Criteria:

* In good health, as determined by the investigator based on a physical examination at screening
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening
* Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
* Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women who are pregnant or lactating
* History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
* History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 175 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 175 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 175 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 175 days
measure: Number of participants with physical examinations abnormalities
timeFrame: Up to 175 days
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 175 days
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to 175 days
measure: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 175 days
measure: Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)]
timeFrame: Up to 175 days
measure: Change in regulatory T cells (Treg) count
timeFrame: Up to 175 days
measure: Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio
timeFrame: Up to 175 days
measure: Number of participants with anti-drug antibodies
timeFrame: Up to 175 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: