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AZD5423

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 2, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

AZD5423 · 7 trials · 5 indications

Phase 2 2Phase 1 5
NCT01555099Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of FormoterolChronic Obstructive Pulmonary Disease (COPD)
COMPLETED353 Analytics
NCT01225549The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled AllergenAsthma
COMPLETED27 Analytics
PHASE2COMPLETED
Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics
PHASE2COMPLETED
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change from baseline to mean of weeks 8 to 12 in pre-dose forced expiratory volume in 1 sec (FEV1)
Baseline (week 0), and at week 8, 10, and 12
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
From Randomization to end of treatment

LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1

Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary
Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.
To investigate the safety and tolerability (AE, blood pressure, pulse, ECG, Body temp, Haematology, Clin Chemistry, Urinalysis, phys exam, lung function) of AZD5423 following administration of single and multiple ascending doses.
10-14 days after last dose
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Safety variables: adverse events
Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination
Frequent sampling occasions during study days

Secondary Endpoints

Percent change from baseline in twenty-four hour plasma cortisol
Baseline (week 0), and at week 4 and 12
Time to first exacerbation (hospitalisation, oral/parenteral corticosteroid, oral/parenteral antibiotics)
Baseline(week 0) and week 2, 4, 8, 10, 12 and daily by eDairy
The percent change from baseline in pre-dose hsCRP at week 4 and 12
Baseline(week 0), and at week 4 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD5423EXPERIMENTALNew study drug
BudesonideACTIVE_COMPARATORComparator to which the new study drug will be compared
PlaceboPLACEBO_COMPARATORNo drug to which both other arms will be compared
1EXPERIMENTALAZD5423 75ug
2EXPERIMENTALAZD5423 300ug
3ACTIVE_COMPARATORBudesonide 200 microgram
4PLACEBO_COMPARATORPlacebo
5EXPERIMENTALAZD5423 inhalation Turbuhaler
6EXPERIMENTALAZD5423, New Dry Powder Inhaler
AEXPERIMENTALDrug: AZD5423
BPLACEBO_COMPARATORDrug: Placebo

Interventions

NameTypeDescription
AZD5423DRUGoral inhaled
BudesonideDRUGoral inhaled
PlaceboDRUGoral inhaled
Budesonide 200 microgramDRUGDry powder for inhalation twice daily 7 days
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Provision of signed and dated informed consent prior to conducting any study specific procedures * Men or women aged ≥ 40 years * Men or post-menopausal or surgically sterile women. Women will be considered post-menopausal if they have been amenorrheic for at least 12 months, ...

Countries:BulgariaFranceHungaryItalyPolandRussiaSlovakiaUkraineCanadaUnited KingdomJapan
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Frequently asked questions about AZD5423

What is AZD5423 used for?

AZD5423 is an investigational small molecule being developed for respiratory conditions, including asthma and chronic obstructive pulmonary disease (COPD). It has been studied in healthy volunteers and patients with mild asthma or COPD. The drug is administered via inhalation and is currently in clinical development, with no approved indications.

What does AZD5423 target?

AZD5423 is a small molecule developed by AstraZeneca for respiratory diseases. While its specific molecular target is not disclosed in available clinical trial information, it is being evaluated for its efficacy in asthma and COPD. The drug is administered via inhalation and has completed Phase 1 and Phase 2 trials.

Who makes AZD5423?

AZD5423 is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD5423 in asthma, COPD, and healthy volunteer studies across multiple countries.

What phase is AZD5423 in?

AZD5423 is in Phase 2 clinical development for asthma and COPD, with Phase 1 studies also completed. All three clinical trials of AZD5423 have been completed, and the drug is not yet approved by regulatory authorities. It remains an investigational agent under evaluation.

What clinical trials is AZD5423 in?

AZD5423 has been studied in three completed clinical trials: NCT01225549 (Phase 2, mild asthma allergen challenge), NCT01310322 (Phase 1, healthy subjects and mild asthmatics), and NCT01555099 (Phase 2, COPD with formoterol background therapy). A fourth trial, NCT01635985, investigated pharmacokinetics in healthy subjects.

Is AZD5423 the same as other asthma medications?

AZD5423 is a distinct investigational compound developed by AstraZeneca, not a marketed asthma medication. It is being studied for asthma and COPD, but it is not yet approved. No alternative names for AZD5423 have been disclosed in clinical trial records.