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QCC374

Phase 2

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Mar 22, 2016

QCC374 development status

Highest phase Phase 2 (NCT02939599)
Phase scored for NVSPhase 1
Registered trials 3 across 1 sponsor since Sep 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

QCC374 clinical trials

QCC374 · 1 trial · 1 indication

Phase 1 1
NCT02245828A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374Healthy Subjects
COMPLETED66 Analytics
PHASE1COMPLETED
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
39 days

Number of Participants with Adverse Events

Secondary Endpoints

AUCinf
39 days
AUClast
39 days
AUCtau
39 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo comparator
QCC374EXPERIMENTALSingle and multiple ascending doses of QCC374

Interventions

NameTypeDescription
QCC374DRUGSingle and multiple ascending doses of QCC374
PlaceboDRUGPlacebo comparator
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory...

Countries:United Kingdom
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Frequently asked questions about QCC374

What is QCC374?

QCC374 is an investigational small molecule developed by Novartis AG. It has been studied in a first-in-human Phase 1 clinical trial in healthy adult subjects. No therapeutic indication for QCC374 has been disclosed, and the compound remains in early clinical development rather than being an approved medicine.

Who makes QCC374?

QCC374 is made and developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the first-in-human study of the compound, which was conducted in the United Kingdom.

What phase is QCC374 in?

QCC374 is in Phase 1 development. Its only recorded clinical trial was a first-in-human Phase 1 study that has been completed. Because no later-stage trials have been reported, QCC374 is investigational and is not an approved therapy.

What clinical trials is QCC374 in?

QCC374 has been evaluated in one clinical trial, NCT02245828, titled a first-in-human study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of QCC374. The Phase 1 trial enrolled 66 healthy subjects in the United Kingdom and is now completed.

How was the QCC374 Phase 1 trial designed?

The QCC374 Phase 1 trial NCT02245828 was a randomized, double-blind, placebo-controlled study of single and multiple ascending doses. It enrolled 66 healthy volunteers aged 18 years and older of any sex and was conducted in the United Kingdom. The study assessed safety, tolerability and pharmacokinetics.

Is QCC374 approved by the FDA?

QCC374 is not an approved medicine. It is an investigational small molecule that has completed a single Phase 1 first-in-human trial, so it remains in early clinical development. No regulatory approval for QCC374 has been granted for any indication.