Recent Updates
Recently added Catalysts

Biochaperone insulin lispro 0.1 U/kg

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 30, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

Biochaperone insulin lispro 0.1 U/kg · 1 trial · 1 indication

Phase 1 1
NCT02660502An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese SubjectsHealthy
COMPLETED15 Analytics
PHASE1COMPLETED
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

AUCLispro(0-30min)
Up to 30 minutes

Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes

Secondary Endpoints

AUCGIR(0-last)
Up to 8 hours
Adverse Events
Up to 10 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BioChaperone insulin lispro 0.1 U/kgEXPERIMENTAL -
BioChaperone insulin lispro 0.2 U/kgEXPERIMENTAL -
BioChaperone insulin lispro 0.4 U/kgEXPERIMENTAL -
Humalog®ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Biochaperone insulin lispro 0.1 U/kgDRUGInjection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
Biochaperone insulin lispro 0.2 U/kgDRUGInjection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
Biochaperone insulin lispro 0.4 U/kgDRUGInjection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
Humalog®DRUGInjection of a single dose of Humalog® at the dose of 0.2 U/kg
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * BMI between 18.5 and 25.0 kg∙m-2, both inclusive. * Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL). * Signed and dat...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about Biochaperone insulin lispro 0.1 U/kg

What is Biochaperone insulin lispro 0.1 U/kg used for?

Biochaperone insulin lispro 0.1 U/kg is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess its pharmacokinetics. The drug is not approved for any indication and is still in clinical development.

Who makes Biochaperone insulin lispro 0.1 U/kg?

Biochaperone insulin lispro 0.1 U/kg is being developed by Eli Lilly and Company, which trades under the ticker LLY. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy subjects.

What phase is Biochaperone insulin lispro 0.1 U/kg in?

Biochaperone insulin lispro 0.1 U/kg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is Biochaperone insulin lispro 0.1 U/kg in?

Biochaperone insulin lispro 0.1 U/kg has one completed clinical trial, NCT02660502, titled "An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects." The trial enrolled 15 participants in Germany.

Is Biochaperone insulin lispro 0.1 U/kg the same as insulin lispro?

Biochaperone insulin lispro 0.1 U/kg is a formulation of insulin lispro combined with a biochaperone technology. It is being studied for its pharmacokinetic profile in healthy subjects. The drug is distinct from standard insulin lispro due to this biochaperone component.