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QAU145

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

QAU145 · 1 trial · 1 indication

Phase 2 1
NCT00506792Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic FibrosisCystic Fibrosis
COMPLETED9 Analytics
PHASE2COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose.
Part I: Baseline, 2 hr post dose, after each dose, end of Part I. Part II: Pre dose and 2 hours post each dose

Secondary Endpoints

Safety and tolerability of single ascending doses assessed by nasal examinations, adverse events, medications, and a nasal symptom questionnaire. Pharmacokinetics up to 6 hours post-dose
Part I: Throughout study (about 8 weeks) Part II: Throughout study (about 9 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALQAU145
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
QAU145DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50. Exclusion Criteria: * Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing. *...

Countries:United States
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Frequently asked questions about QAU145

What is QAU145 used for in cystic fibrosis?

QAU145 is an investigational small molecule being studied for the treatment of cystic fibrosis. It was evaluated in a Phase 2 clinical trial to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with the condition. The drug is not approved and remains in clinical development.

Who makes QAU145?

QAU145 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company sponsored the Phase 2 clinical trial of QAU145 in patients with cystic fibrosis.

What phase is QAU145 in?

QAU145 is in Phase 2 clinical development. A Phase 2 trial of the drug in patients with cystic fibrosis has been completed. QAU145 is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is QAU145 in?

QAU145 has been studied in one clinical trial, identified as NCT00506792. This was a Phase 2, randomized, double-blind, placebo-controlled study titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis." The trial enrolled 9 participants in the United States and has been completed.

Is QAU145 FDA approved?

QAU145 is not FDA approved. It is an investigational small molecule that has completed a Phase 2 clinical trial in patients with cystic fibrosis. The drug is still in clinical development and has not been authorized for commercial use.