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18F-BMS-986327

Phase 1

Healthy Participants | Unknown | Respiratory |Bristol-Myers Squibb Company|Last Updated: Mar 7, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

18F-BMS-986327 · 1 trial · 2 indications

Phase 1 1
NCT04069143A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327Healthy Participants
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 3 days after participant's participation
Incidence of serious adverse events (SAEs)
Up to 30 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
30 days after participant's participation
Test-retest repeatability
30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
30 days after participant's participation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -

Interventions

NameTypeDescription
18F-BMS-986327DIAGNOSTIC_TESTImaging Agent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All Participants: · Body mass index of 18.0 to 34.0 kg/m\^2, inclusive, and body weight ≥ 50 kg Healthy Participants: * Male and female healthy volunteers ages 18 or age or older * No clinically significant deviation from normal in medical history, physical examination, elect...

Countries:United States
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Frequently asked questions about 18F-BMS-986327

What is 18F-BMS-986327?

18F-BMS-986327 is an investigational radiopharmaceutical being developed by Bristol-Myers Squibb Company (BMY). It is currently in Phase 1 clinical development for use in healthy participants and in patients with idiopathic pulmonary fibrosis (IPF). The drug is being studied for its safety, tolerability, kinetics, and repeatability.

What is 18F-BMS-986327 used for?

18F-BMS-986327 is being studied for use in healthy participants and in patients with idiopathic pulmonary fibrosis (IPF). The ongoing clinical trial evaluates its safety, tolerability, kinetics, and repeatability in these populations. It is an investigational drug and has not been approved by regulatory authorities.

Who makes 18F-BMS-986327?

18F-BMS-986327 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's safety and other properties in a Phase 1 study.

What phase is 18F-BMS-986327 in?

18F-BMS-986327 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in healthy participants and in patients with idiopathic pulmonary fibrosis (IPF). The drug is investigational and has not been approved by the FDA or other regulatory agencies.

What clinical trials is 18F-BMS-986327 in?

18F-BMS-986327 has one completed clinical trial, registered under the identifier NCT04069143. The study, titled "A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327," enrolled 14 participants in the United States and included healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF).

Is 18F-BMS-986327 FDA approved?

18F-BMS-986327 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 study evaluated its safety, tolerability, kinetics, and repeatability in healthy participants and in patients with idiopathic pulmonary fibrosis (IPF), but the drug remains under investigation.