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RO5469754

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Aug 28, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

RO5469754 · 1 trial · 1 indication

Phase 1 1
NCT01620931A Single-Ascending-Dose Study of RO5469754 in Healthy VolunteersHealthy Volunteer
COMPLETED36 Analytics
PHASE1COMPLETED
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
approximately 1 year

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC)
Pre-dose and up to 72/120 hours post-dose, and at follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5469754EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGSingle doses, iv or sc
RO5469754DRUGSingle ascending doses, iv or sc
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteers, 18 to 64 years of age, inclusive * Body mass index (BMI) 18 to 32 kg/m2 * Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the e...

Countries:Netherlands
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Frequently asked questions about RO5469754

What is RO5469754?

RO5469754 is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains under investigation.

What is RO5469754 used for?

RO5469754 is being studied for use in healthy volunteers as part of early clinical research. Its purpose is to evaluate the safety, tolerability, and pharmacokinetics of the drug in humans. It is not yet approved for any medical condition.

Who makes RO5469754?

RO5469754 is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.

What phase is RO5469754 in?

RO5469754 is in Phase 1 clinical development. A single-ascending-dose study in healthy volunteers has been completed. The drug remains investigational and has not received regulatory approval.

What clinical trials is RO5469754 in?

RO5469754 has one completed Phase 1 trial, NCT01620931, titled "A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers." The study enrolled 36 participants in the Netherlands and was placebo-controlled, though not double-blinded.

Is RO5469754 the same as any other drug?

No alternative names for RO5469754 have been identified. The drug is known by its developmental code name RO5469754 and is being studied by Roche Holding AG.