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inclacumab

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

inclacumab · 1 trial · 1 indication

Phase 1 1
NCT01815827A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy VolunteersHealthy Volunteer
COMPLETED62 Analytics
PHASE1COMPLETED
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
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Study Endpoints

Primary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC)
up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
up to 197 days

Secondary Endpoints

Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
up to 197 days
Pharmacodynamics: Plasma (free and total) soluble P-selectin
up to 197 days
Safety: Incidence of adverse events
approximately 10 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Caucasian Healthy volunteersACTIVE_COMPARATOR -
Japanese Healthy volunteersEXPERIMENTAL -

Interventions

NameTypeDescription
inclacumabDRUGsingle intravenous doses
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination * Japanese subjects must have Japanese p...

Countries:United States
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Frequently asked questions about inclacumab

What is inclacumab used for?

Inclacumab is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and remains in clinical development. The completed Phase 1 trial evaluated a single dose in Japanese and Caucasian healthy volunteers to assess its safety and pharmacokinetics.

Who makes inclacumab?

Inclacumab is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored the Phase 1 clinical trial of the drug in healthy volunteers.

What phase is inclacumab in?

Inclacumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single completed Phase 1 trial involved 62 healthy volunteers.

What clinical trials is inclacumab in?

Inclacumab has one completed clinical trial, NCT01815827, titled "A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers." This Phase 1 study enrolled 62 participants in the United States and was completed.

Is inclacumab the same as any other drug?

No alternative names for inclacumab have been reported. It is identified by its single name in clinical trial records and development documentation.