COMPLETED

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

Conditions

Healthy Volunteer Bioavailability Study Subcutaneous Injection Anti-MTBR Tau Monoclonal Antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants

Quick Facts

Study Start:2025-05-05

Study Completion:2025-09-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06955741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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). * Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion Criteria

Exclusion 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.

* 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).
* Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0001

Anaheim, California, 92801

United States

Local Institution - 10000

Anaheim, California, 92801

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05

Study Completion Date2025-09-11

Study Record Updates

Study Start Date2025-05-05

Study Completion Date2025-09-11

Terms related to this study

Keywords Provided by Researchers

Bioavailability Study
Subcutaneous Injection
Anti-MTBR Tau Monoclonal Antibody

Additional Relevant MeSH Terms

Healthy Volunteer