Recent Updates
Recently added Catalysts

LY3000328

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: May 31, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

LY3000328 · 1 trial · 1 indication

Phase 1 1
NCT01515358A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy ParticipantsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Baseline to study completion (estimate 3 months)

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328
Pre-dose up to Day 6 post-dose
Pharmacokinetics: Maximum concentration (Cmax) of LY3000328
Pre-dose up to Day 6 post-dose
Change in Cathepsin S (CatS) activity
Pre-dose, up to 48 hours post-dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORSingle dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.
LY3000328EXPERIMENTALSingle escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.

Interventions

NameTypeDescription
PlaceboDRUGAdministered orally
LY3000328DRUGAdministered orally
Unlock Study Design Details

Eligibility Criteria

Age Range35 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination

Countries:Singapore
Unlock Eligibility Criteria

Frequently asked questions about LY3000328

What is LY3000328?

LY3000328 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety and tolerability. It is not approved by the FDA and remains in clinical development.

What is LY3000328 used for?

LY3000328 is being studied for use in healthy volunteers. The primary purpose of the clinical trial was to evaluate the safety and tolerability of the drug in healthy participants. It is not intended for a specific disease indication at this stage of development.

Who makes LY3000328?

LY3000328 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company conducted a Phase 1 clinical trial to assess the drug's safety and tolerability in healthy participants.

What phase is LY3000328 in?

LY3000328 is in Phase 1 clinical development. A Phase 1 trial has been completed, which involved 18 healthy participants. The study was randomized, double-blind, and placebo-controlled. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY3000328 in?

LY3000328 has been studied in one clinical trial, identified as NCT01515358. This was a Phase 1 study titled 'A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants.' The trial was completed and enrolled 18 participants in Singapore.

Is LY3000328 the same as any other drug?

LY3000328 is the only name provided for this drug. No alternative names have been identified in the available information. It is a distinct investigational small molecule being developed by Eli Lilly and Company.