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RO5469754

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Aug 28, 2025

RO5469754 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2012

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

RO5469754 clinical trials

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
Healthy VolunteerUnlock trial analytics

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

Who is developing RO5469754?

RO5469754 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 RO5469754 in?

RO5469754 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is RO5469754 in?

RO5469754 has been evaluated in one completed Phase 1 trial, NCT01620931, titled A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers. The trial enrolled 36 healthy adult participants in the Netherlands and used a randomized, placebo-controlled design.

What is RO5469754 used for?

The therapeutic use of RO5469754 has not been disclosed. Its only reported clinical study was a Phase 1 single-ascending-dose trial conducted in healthy volunteers, so no patient population or indication has been publicly identified for this investigational small molecule.