NCT06955741

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

April 25, 2025

Last Update Submit

September 26, 2025

Conditions

Healthy Volunteer

Keywords

Bioavailability StudySubcutaneous InjectionAnti-MTBR Tau Monoclonal Antibody

Outcome Measures

Primary Outcomes (4)

  • Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC

    Up to approximately Day 85

  • GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC

    Up to approximately Day 85

  • GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC

    Up to approximately Day 85

  • Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion

    Up to approximately Day 85

Secondary Outcomes (20)

  • Number of Participants With Adverse Events (AEs)

    Up to approximately Day 85

  • Number of Participants With Serious Adverse Events (SAEs)

    Up to approximately Day 85

  • Number of Participants With AEs Reported Related to BMS-986446

    Up to approximately Day 85

  • Number of Participants With Clinically Significant Vital Sign Abnormalities

    Up to approximately Day 85

  • Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

    Up to approximately Day 85

  • +15 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: BMS-986446 IVDrug: AcetaminophenDrug: Loratadine

Arm B

EXPERIMENTAL
Drug: BMS-986446 SCDrug: AcetaminophenDrug: Loratadine

Interventions

BMS-986446 IVDRUG

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

Arm A
BMS-986446 SCDRUG

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

Arm B
AcetaminophenDRUG

Specified dose on specified days

Arm AArm B
LoratadineDRUG

Specified dose on specified days

Arm AArm B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Local Institution - 10000

Anaheim, California, 92801, United States

Location

Related Links

MeSH Terms

Interventions

AcetaminophenLoratadine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 2, 2025

Study Start

May 5, 2025

Primary Completion

September 11, 2025

Study Completion

September 11, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.htm

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See plan description
Access Criteria
See plan description
More information

Locations

US(2)