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AZD2423

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 10, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

AZD2423 · 7 trials · 7 indications

Phase 2 4Phase 1 3
NCT01153321Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease
COMPLETED71 Analytics
NCT01200524A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..Nerve Pain
COMPLETED133 Analytics
NCT01215279AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)Chronic Obstructive Pulmonary Disease
COMPLETED63 Analytics
NCT01201317A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic PolyneuropathyNeuropathic Pain
COMPLETED134 Analytics
PHASE2COMPLETED
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Nerve PainUnlock trial analytics
PHASE2COMPLETED
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute Monocyte Count in BAL Post-LPS Challenge
Day 11

Monocyte count in BAL post-LPS challenge (Day 11)

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.

Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points

Number of Participants With Clinically Significant Changes in Vital Signs
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in vital signs assessed at all the listed time points

Number of Participants With Clinically Significant Changes in ECG Variables
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in ECG variables assessed at all the listed time points

Number of Participants With Clinically Significant Changes in Physical Examination
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in physical examination assessed at all the listed time points

Monocytes at Baseline
Day 1

Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)

Monocytes at End of Treatment
week 4

Monocyte count in peripheral blood at end of treatment (4 weeks)

Monocytes at Follow-up
week 5 (follow-up)

Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)

Number of participants with Adverse events
Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs
Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)

Changes from baseline in systolic blood pressure, pulse rate and body temperature

Electrocardiograms
Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Laboratory Variables (hematology, urinalysis and clinical chemistry)
Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
From screening period to follow-up visit, 40 days (Maximum).
To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.
3 day residential period plus 7-10 days follow up

Secondary Endpoints

Total Neutrophils in Biopsy Sample (Post-LPS Challenge)
Day 11
Total Macrophages in Biopsy Sample (Post-LPS Challenge)
Day 11
CD45+ in Biopsy Sample (Post-LPS Challenge)
Day 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOral treatment
2PLACEBO_COMPARATOROral treatment
AZD2423, 20mgEXPERIMENTAL -
AZD2423, 150 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATORTablet to match the 20 mg and 50 mg AZD2423 active tablet
AZD2423EXPERIMENTALAZD2423 Oral Treatment for 28 days
AZD2423, 20 mgEXPERIMENTALTablets, 20 mg once daily in the morning.
1. AZD2423EXPERIMENTAL -
2. PlaceboPLACEBO_COMPARATOR -
AEXPERIMENTALAZD2423
BEXPERIMENTALPlacebo

Interventions

NameTypeDescription
AZD2423DRUG100mg Oral dose od
AZD2423 PlaceboDRUGOral dose od
PlaceboDRUGPlacebo
Placebo to AZD2423DRUGOral treatment once daily for 28 days
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal. * ≥ 40 years of age at Visit 1 * Clinical diagnosis of COPD (GOLD stage 1) * FEV1 ≥ 80% of the predicted normal post-bronchodilator a...

Countries:GermanyBulgariaDenmarkFrancePolandRussiaSwedenUnited KingdomSlovakiaUnited StatesCanadaJapan
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Frequently asked questions about AZD2423

What is AZD2423 used for?

AZD2423 is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD) and neuropathic pain. Clinical trials have evaluated it in healthy volunteers and in patients with mild, moderate, and severe COPD. It is not approved and remains in clinical development.

Who makes AZD2423?

AZD2423 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company has sponsored clinical trials of AZD2423 in healthy volunteers and in patients with chronic obstructive pulmonary disease.

What phase is AZD2423 in?

AZD2423 has completed Phase 1 and Phase 2 clinical trials. Phase 1 studies assessed safety and tolerability in healthy volunteers, while Phase 2 studies evaluated its effects in patients with chronic obstructive pulmonary disease. All trials are completed, and the drug remains investigational.

What clinical trials is AZD2423 in?

AZD2423 has been studied in four completed clinical trials. NCT00970775 and NCT01233830 were Phase 1 studies in healthy Japanese volunteers. NCT01153321 and NCT01215279 were Phase 2 studies in patients with chronic obstructive pulmonary disease. All trials are completed.

Is AZD2423 the same as another drug?

AZD2423 is the code name used by AstraZeneca for this investigational compound. No alternative brand or generic names have been disclosed in the clinical trial records. It is identified solely by the code AZD2423 in all registered studies.