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RO7033877

Phase 1

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

RO7033877 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jun 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

RO7033877 clinical trials

RO7033877 · 1 trial · 1 indication

Phase 1 1
NCT02165293A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy VolunteersHealthy Volunteer
COMPLETED32 Analytics
PHASE1COMPLETED
A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC
5 days (in-clinic period)
ELF and AM/Plasma Ratios of Cmax and AUC
5 days (in-clinic period)

Secondary Endpoints

Incidence of adverse events (AEs)
Up to 12 days
Changes in clinical laboratory safety tests, vital signs, and ECGs
Up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
RO7033877EXPERIMENTAL -

Interventions

NameTypeDescription
RO7033877 + BronchoscopyDRUGDays 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female participant is eligible to participate if she is of non-childbearing potential defined as postmenopausal or surgically sterile * Healthy status is defined by absence of evidence of any active or chro...

Countries:United States
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Frequently asked questions about RO7033877

What is RO7033877?

RO7033877 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers, with a focus on measuring how the compound penetrates into the lung. It is not an approved medicine and remains in clinical development.

Who makes RO7033877?

RO7033877 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in healthy volunteers. No other developer or partner is associated with the program based on the trial record.

What phase is RO7033877 in?

RO7033877 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 32 healthy volunteers and was conducted in the United States. The drug is investigational and has not been approved for any use.

What clinical trial has been conducted with RO7033877?

RO7033877 has been evaluated in trial NCT02165293, titled a single center study to evaluate the penetration of RO7033877 into the lung in healthy volunteers. The Phase 1 trial enrolled 32 participants, was randomized, and has been completed. It was conducted in the United States.

What is RO7033877 used for?

RO7033877 has been studied in healthy volunteers rather than in a patient population, so no therapeutic indication has been disclosed. The completed Phase 1 trial, NCT02165293, assessed lung penetration of the compound. It is an investigational agent and is not approved for any indication.