Recent Updates
Recently added Catalysts

RO5428029

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Roche Holding AG|Trials Updated: Nov 2, 2016

RO5428029 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

RO5428029 clinical trials

RO5428029 · 1 trial · 1 indication

Phase 1 1
NCT01371162A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis CHepatitis C, Chronic, Healthy Volunteer
COMPLETED42 Analytics
PHASE1COMPLETED
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
Hepatitis C, Chronic, Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
up to 17 days
Parts A + B: Safety: Incidence of adverse events
up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
up to 24 days

Secondary Endpoints

Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
up to 17 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
A1 Healthy VolunteersEXPERIMENTAL -
A2PLACEBO_COMPARATOR -
B1 HCV InfectionEXPERIMENTAL -
B2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RO5428029DRUGMultiple ascending doses
placeboDRUGmultiple doses
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive * Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg * Female subjects/patients must be surgically sterile or post-menopausa...

Countries:FranceNetherlandsPoland
Unlock Eligibility Criteria

Frequently asked questions about RO5428029

What is RO5428029?

RO5428029 is an investigational small molecule developed by Roche Holding AG for chronic hepatitis C. It is in Phase 1 clinical development and has been studied in a single completed trial that enrolled 42 participants, including healthy volunteers and patients with chronic hepatitis C.

What is RO5428029 used for?

RO5428029 is being developed for the treatment of chronic hepatitis C, an infectious disease of the liver. It is an investigational agent and has not been approved for any indication. Its only reported clinical study enrolled patients with chronic hepatitis C alongside healthy volunteers.

Who makes RO5428029?

RO5428029 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the compound's clinical program in chronic hepatitis C.

What phase is RO5428029 in?

RO5428029 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The program's single reported trial has been completed, and no active trials are currently listed.

What clinical trials is RO5428029 in?

RO5428029 has been studied in one completed Phase 1 trial, NCT01371162, titled A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C. The trial enrolled 42 participants across France, the Netherlands, and Poland, was randomized, double blind, and placebo controlled, and included adults 18 years and older.