A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

NCT ID: NCT06955741

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-09-11

Brief Summary

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The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

BMS-986446 IV

Intervention Type DRUG

Specified dose on specified days was administered intravenously (IV).

Acetaminophen

Intervention Type DRUG

Specified dose on specified days

Loratadine

Intervention Type DRUG

Specified dose on specified days

Arm B

Group Type EXPERIMENTAL

BMS-986446 SC

Intervention Type DRUG

Specified dose on specified days was administered subcutaneously (SC).

Acetaminophen

Intervention Type DRUG

Specified dose on specified days

Loratadine

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986446 IV

Specified dose on specified days was administered intravenously (IV).

Intervention Type DRUG

BMS-986446 SC

Specified dose on specified days was administered subcutaneously (SC).

Intervention Type DRUG

Acetaminophen

Specified dose on specified days

Intervention Type DRUG

Loratadine

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
* Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.

Exclusion Criteria

* Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
* Participants must not have prior exposure to BMS-986446 (PRX005).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Anaheim, California, United States

Site Status

Local Institution - 10000

Anaheim, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CN008-0026

Identifier Type: -

Identifier Source: org_study_id

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