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RO6926496

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

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

RO6926496 · 1 trial · 1 indication

Phase 1 1
NCT02281786A Study of RO6926496 in Healthy VolunteersHealthy Volunteer
COMPLETED48 Analytics
PHASE1COMPLETED
A Study of RO6926496 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 16 weeks

Secondary Endpoints

Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance
Up to 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL8 volunteers (6 active, 2 placebo)
Cohort 2EXPERIMENTAL8 volunteers (6 active, 2 placebo)
Cohort 3EXPERIMENTAL8 volunteers (6 active, 2 placebo)
Cohort 4EXPERIMENTAL8 volunteers (6 active, 2 placebo)
Cohort 5EXPERIMENTAL8 volunteers (6 active, 2 placebo)
Cohort 6EXPERIMENTAL8 volunteers (6 active, 2 placebo)

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo to RO6926496
RO6926496DRUGsingle, ascending dose, intravenous administration
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history * A body mass index between 18 and 30 kg/m2 * Male subjects and their partners of childbearing ...

Countries:United Kingdom
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Frequently asked questions about RO6926496

What is RO6926496?

RO6926496 is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy volunteers, with a total enrollment of 48 participants.

What is RO6926496 used for?

RO6926496 is being studied for use in healthy volunteers. The completed Phase 1 trial was designed to evaluate the drug in this population. Its potential therapeutic application has not been established, as it is still in early-stage clinical development.

Who makes RO6926496?

RO6926496 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical trial for this investigational small molecule. The drug is currently in Phase 1 development.

What phase is RO6926496 in?

RO6926496 is in Phase 1 clinical development. The drug has completed one Phase 1 trial in healthy volunteers. It is an investigational agent and has not been approved for any use. Further clinical development status is not specified.

What clinical trials is RO6926496 in?

RO6926496 has been studied in one completed clinical trial, NCT02281786, titled "A Study of RO6926496 in Healthy Volunteers." This Phase 1 trial enrolled 48 healthy male participants aged 18 years and older in the United Kingdom. The trial was randomized, double-blind, and controlled.

Is RO6926496 FDA approved?

RO6926496 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed a Phase 1 trial in healthy volunteers, but no approval status has been established. It remains under investigation by Roche Holding AG.