NCT06955741

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	BMS-986446 IV	Specified dose on specified days was administered intravenously (IV).
DRUG	BMS-986446 SC	Specified dose on specified days was administered subcutaneously (SC).
DRUG	Acetaminophen	Specified dose on specified days
DRUG	Loratadine	Specified dose on specified days

Timeline

• Start date: 2025-05-05
• Primary completion: 2025-09-11
• Completion: 2025-09-11
• First posted: 2025-05-02
• Last updated: 2025-10-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study