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Prenisolone

Phase 1

Immunoscience | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Dec 6, 2019

Success Probability

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Prenisolone · 1 trial · 1 indication

Phase 1 1
NCT03196557A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male SubjectImmunoscience
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
ImmunoscienceUnlock trial analytics

Study Endpoints

Primary Endpoints

Interleukin 1 beta
Up to 32 days

As measured by flow cytometry

Tumor necrosis factor-alpha
Up to 32 days

As measured by flow cytometry

Receptor activator of nuclear factor-kB (RANK)
Up to 32 days

As measured by flow cytometry

Receptor activator of nuclear factor-kB ligand (RANKL)
Up to 32 days

As measured by flow cytometry

Osteoprotegrin (OPG)
Up to 32 days

As measured by flow cytometry

Lipopolysaccharide Induced Cytokine Production
Up to 32 days

As measured by blood concentration

Cell Populations
Up to 32 days

As measured by flow cytometry

Oral glucose tolerance test
Up to 32 days

Assessed by central labortatory

Cortisol
Up to 32 days

As measured by the level of the hormone cortisol in the blood

Adrenocorticotropic hormone
Up to 32 days

As measured by the level of the hormone in the blood

Osteocalcin
Up to 32 days

As measured by blood concentration

N-terminal Pro-Collagen Peptide (PINP)
Up to 32 days

As measured by blood concentration

Propetide type I C-term Pro-collagen Peptide (CICP)
Up to 32 days

As measured by blood concentration

Bone-specific alkaline phosphatase
Up to 32 days

As measured by blood concentration

Urinary deoxypyridinoline
Up to 32 days

As measured by urine concentration

C Telopeptide of Collagen Type II (CTX-II)
Up to 32 days

As measured by urine concentration

Calcium
Up to 32 days

As measured by urine concentration

Creatinine
Up to 32 days

As measured by urine concentration

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALSpecified dose on specified days
Arm BPLACEBO_COMPARATORSpecified dose on specified days

Interventions

NameTypeDescription
PrenisoloneDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive * Signed informed consen...

Countries:United States
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Frequently asked questions about Prenisolone

What is Prenisolone used for?

Prenisolone is a small molecule being developed for immunoscience, an area of immunology research. It is currently in Phase 1 clinical development as an investigational drug. The drug is being studied for its pharmacodynamic effects in healthy subjects, with a focus on understanding its activity in the immune system.

Who makes Prenisolone?

Prenisolone is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this small molecule candidate for immunoscience applications. Bristol-Myers Squibb is responsible for the drug's development program, including its Phase 1 clinical trial.

What phase is Prenisolone in?

Prenisolone is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical testing. The Phase 1 trial for Prenisolone has been completed, and the drug remains in early-stage development for immunoscience.

What clinical trials is Prenisolone in?

Prenisolone has one completed Phase 1 clinical trial registered under NCT03196557. The study, titled "A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject," enrolled 24 healthy male participants in the United States. The trial was placebo-controlled and assessed the drug's pharmacodynamic effects.

Is Prenisolone the same as Prednisoline?

Prenisolone is also referred to as Prednisoline in clinical trial documentation. The Phase 1 study NCT03196557 uses the name Prednisoline in its title, while the drug is otherwise known as Prenisolone. Both names refer to the same investigational small molecule being developed by Bristol-Myers Squibb.