Recent Updates
Recently added Catalysts

inclacumab

Phase 3

Undisclosed | Monoclonal antibody | Other |Roche Holding AG|Trials Updated: Nov 2, 2016

inclacumab development status

Highest phase Phase 3 run by Pfizer (NCT05348915)
Phase scored for RHHBYPhase 1
Registered trials 4 across 2 sponsors since Mar 2013

inclacumab target and mechanism

Molecular targetSELP
Target classAntagonist
ModalityMonoclonal antibody

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

inclacumab clinical trials

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
Healthy VolunteerUnlock trial analytics

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Caucasian Healthy volunteersACTIVE_COMPARATOR -
Japanese Healthy volunteersEXPERIMENTAL -

Interventions

NameTypeDescription
inclacumabDRUGsingle intravenous doses
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about inclacumab

What is inclacumab?

Inclacumab is an investigational monoclonal antibody developed by Roche Holding AG (ticker RHHBY). It is a P-selectin antagonist that has been studied in Phase 1 clinical trials. It is not an approved medicine, and its clinical development remains at the early-stage Phase 1 level.

What does inclacumab target?

Inclacumab targets SELP, the gene encoding P-selectin, and acts as an antagonist of that target. By binding P-selectin, the monoclonal antibody is designed to block P-selectin mediated interactions. P-selectin is a cell adhesion molecule involved in the recruitment of leukocytes and platelets.

Who makes inclacumab?

Inclacumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program for this monoclonal antibody. The asset is identified in public drug databases under the ChEMBL identifier CHEMBL2109488.

What phase is inclacumab in?

Inclacumab is in Phase 1 clinical development. It is an investigational monoclonal antibody and is not an approved product. The Phase 1 program has completed, with one trial recorded and no active trials at this time.

What clinical trials is inclacumab in?

Inclacumab has been evaluated in the Phase 1 trial NCT01815827, titled A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers. That trial enrolled 62 healthy adult volunteers in the United States, used an active-controlled randomized design, and has completed.