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Peresolimab

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 29, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

Peresolimab · 1 trial · 1 indication

Phase 1 1
NCT05959109A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy ParticipantsHealthy
COMPLETED57 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab
Predose up to 85 days postdose

PK: Cmax of Peresolimab

PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of Peresolimab
Predose up to 85 days postdose

PK: AUC\[0-tlast\] of Peresolimab

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Peresolimab
Predose up to 85 days postdose

PK: AUC(0-∞) of Peresolimab

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Peresolimab (Test 1)EXPERIMENTALPeresolimab administered subcutaneously (SC).
Peresolimab (Test 2)EXPERIMENTALPeresolimab administered SC.
Peresolimab (Test 3)EXPERIMENTALPeresolimab administered SC.
Peresolimab (Reference)EXPERIMENTALPeresolimab administered SC.

Interventions

NameTypeDescription
PeresolimabDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are overtly healthy as determined by medical history, physical examination, and other screening procedures * A minimum body weight of 45 kilograms and body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, a...

Countries:United States
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Frequently asked questions about Peresolimab

What is Peresolimab used for?

Peresolimab is an investigational small molecule being studied in healthy participants. It is being evaluated in a clinical trial to assess the relative bioavailability of different Peresolimab formulations. The drug is not approved for any disease and is in early-stage clinical development.

Who makes Peresolimab?

Peresolimab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational small molecule drug.

What phase is Peresolimab in?

Peresolimab is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in healthy volunteers to evaluate the bioavailability of its formulations.

What clinical trials is Peresolimab in?

Peresolimab has one completed Phase 1 clinical trial registered as NCT05959109. This study, titled "A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants," enrolled 57 healthy adults in the United States and evaluated the bioavailability of different drug formulations.

Is Peresolimab the same as LY3462817?

Yes, Peresolimab is also known as LY3462817. The clinical trial NCT05959109 references this alternative name in its title, confirming that both names refer to the same investigational drug being developed by Eli Lilly and Company.