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MHAA549A

Phase 2

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Mar 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

MHAA549A · 1 trial · 1 indication

Phase 2 1
NCT01980966A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge ModelHealthy Volunteer
COMPLETED101 Analytics
PHASE2COMPLETED
A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model
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Study Endpoints

Primary Endpoints

Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
8 days

Secondary Endpoints

Safety: Incidence of adverse events
120 days
Safety: Change in lung function
from pre-challenge to Day 29
Safety: Incidence of anti-therapeutic antibodies (ATAs)
120 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
MHAA4549AEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
TamifluACTIVE_COMPARATOR -

Interventions

NameTypeDescription
MHAA549ADRUGIV dose
PlaceboDRUGIV dose
oseltamivir [Tamiflu]DRUGOrally b.i.d, 5 days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests * Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and ...

Countries:United Kingdom
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Frequently asked questions about MHAA549A

What is MHAA549A?

MHAA549A is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 2 clinical development. The drug has been studied in healthy volunteers, specifically in an influenza challenge model, to evaluate its effects.

What is MHAA549A used for?

MHAA549A is being studied for use in healthy volunteers, particularly in an influenza challenge model. This means it is being tested to see how it affects healthy individuals who are exposed to the influenza virus in a controlled setting. The drug is still in clinical development and is not yet approved.

Who makes MHAA549A?

MHAA549A is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is a multinational healthcare company that operates in pharmaceuticals and diagnostics. The drug is currently in Phase 2 clinical trials.

What phase is MHAA549A in?

MHAA549A is in Phase 2 clinical development. It has completed one Phase 2 trial in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. It is still undergoing clinical testing to assess its safety and efficacy.

What clinical trials is MHAA549A in?

MHAA549A has one completed clinical trial, identified as NCT01980966. This was a Phase 2 study titled 'A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model.' The trial was conducted in the United Kingdom and enrolled 101 participants. It was a randomized, double-blind, placebo-controlled study.

Is MHAA549A the same as MHAA4549A?

Yes, MHAA549A is also known as MHAA4549A. The clinical trial NCT01980966, which studied the drug in healthy volunteers, uses the name MHAA4549A in its title. Both names refer to the same investigational drug being developed by Roche.