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RO7033877+ Bronchoscopy

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

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

RO7033877+ Bronchoscopy · 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+ Bronchoscopy

What is RO7033877 used for?

RO7033877 is an investigational small molecule being studied in healthy volunteers. A completed Phase 1 trial evaluated its penetration into the lung. It is not approved for any indication and remains in clinical development.

Who makes RO7033877?

RO7033877 is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company conducted a Phase 1 study of the drug in healthy volunteers in the United States.

What phase is RO7033877 in?

RO7033877 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO7033877 in?

RO7033877 was studied in a single completed Phase 1 trial, NCT02165293, titled 'A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers.' The trial enrolled 32 participants in the United States and was not blinded or controlled.

Is RO7033877 the same as Bronchoscopy?

RO7033877 is sometimes referred to as RO7033877+ Bronchoscopy, which reflects the bronchoscopy procedure used in the clinical trial to measure lung penetration. The drug itself is a small molecule, and the trial involved healthy volunteers aged 18 years and older.