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RG7667

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

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

RG7667 · 1 trial · 1 indication

Phase 1 1
NCT01496755A Study of RG7667 in Healthy VolunteersHealthy Volunteer
COMPLETED170 Analytics
PHASE1COMPLETED
A Study of RG7667 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
up to 141 days

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC)
up to 141 days
Pharmacokinetic: Maximum serum concentration (Cmax)
up to 141 days
Pharmacokinetic: Time to maximum serum concentration (tmax)
up to 141 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RG7667EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGSingle/multiple doses
RG7667DRUGSingle/multiple ascending doses
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Male and female subjects, 18 to 55 years of age, inclusive * Body mass index 18.0 to 31.0 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory values, as deemed by the Investigator E...

Countries:United States
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Frequently asked questions about RG7667

What is RG7667 used for?

RG7667 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, and the completed trial evaluated its safety and tolerability in healthy participants. The drug is not approved for any indication and remains under investigation.

Who makes RG7667?

RG7667 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 study of the drug in healthy volunteers in the United States.

What phase is RG7667 in?

RG7667 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated.

What clinical trials is RG7667 in?

RG7667 has one completed clinical trial, NCT01496755, titled "A Study of RG7667 in Healthy Volunteers." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 170 participants in the United States and included healthy adults aged 18 years and older.

Is RG7667 FDA approved?

RG7667 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. The drug is still in clinical development, and its safety and efficacy have not been established for any medical condition.