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RO6926496

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Nov 2, 2016

RO6926496 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2014

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

RO6926496 clinical trials

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 developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult male volunteers in the United Kingdom. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early clinical development.

Who makes RO6926496?

RO6926496 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program for this investigational small molecule.

What phase is RO6926496 in?

RO6926496 is in Phase 1 clinical development. Its only recorded trial, NCT02281786, was a Phase 1 study in healthy volunteers that has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is RO6926496 in?

RO6926496 has been evaluated in one clinical trial, NCT02281786, titled A Study of RO6926496 in Healthy Volunteers. The Phase 1 trial enrolled 48 participants in the United Kingdom, was randomized, double-blind, and controlled, and is now completed. No active trials are currently listed.

What is RO6926496 used for?

The therapeutic use of RO6926496 has not been publicly disclosed. Its completed Phase 1 trial, NCT02281786, was conducted in healthy adult male volunteers rather than in patients with a specific disease, which is typical for early-stage safety and tolerability studies of an investigational small molecule.

How was the RO6926496 Phase 1 trial designed?

The Phase 1 trial of RO6926496, NCT02281786, was a randomized, double-blind, controlled study conducted in the United Kingdom. It enrolled 48 healthy male volunteers aged 18 years and older. The study has been completed, and no biomarker-based patient selection was used.