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AZD7624

Phase 2

Chronic Obstructive Pulmonary Disease COPD | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: May 24, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment213

FDA Designations

No designations recorded

Clinical trial landscape

AZD7624 · 4 trials · 5 indications

Phase 2 1Phase 1 3
NCT02238483A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance TherapyChronic Obstructive Pulmonary Disease COPD
COMPLETED213 Analytics
PHASE2COMPLETED
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
Chronic Obstructive Pulmonary Disease COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms
Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
Description of the pharmacodynamic Neutrophil lipopolysaccharide (LPS) response after a single dose AZD7624 in terms of % change in neutrophil differential from baseline
Sample taken at baseline visit (7-14 days before dose) and at 6h after dose day1 for each treatment. (up to 7 weeks)
Adverse Events
Up to 24 days

Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)

Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
up to 55 days.

Secondary Endpoints

Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)
Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)
Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)
Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD7624EXPERIMENTALActive treatment
PlaceboPLACEBO_COMPARATORPlacebo Comparator
1EXPERIMENTALGroups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo.
2PLACEBO_COMPARATORGroups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo.
Group 1-5, single ascending dose AZD7624EXPERIMENTALSubjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.

Interventions

NameTypeDescription
AZD7624 1.0 mgDRUGInhaled AZD7624 solution, 11 mg/mL
PlaceboDRUGInhaled placebo solution
AZD7624DRUGnebuliser solution; 20 mg/mL for inhalation
Placebo to matchDRUGMultiple doses inhaled placebo via a nebulizer
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures. * Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically...

Countries:United StatesArgentinaChileNetherlandsPeruSouth AfricaUnited Kingdom
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Frequently asked questions about AZD7624

What is AZD7624 used for?

AZD7624 is an investigational small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD). It has been studied in healthy volunteers and COPD patients, including a Phase IIa trial in COPD patients on maintenance therapy. The drug is not approved and remains in clinical development.

Who makes AZD7624?

AZD7624 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca has conducted clinical trials of AZD7624 in the United Kingdom, United States, and several other countries.

What phase is AZD7624 in?

AZD7624 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase IIa trial in COPD patients, which has been completed. AZD7624 is an investigational drug and has not received FDA approval.

What clinical trials is AZD7624 in?

AZD7624 has been studied in four completed clinical trials. These include NCT01754844, a first-in-human study in healthy subjects; NCT01817855, a safety and pharmacokinetics study in healthy volunteers and COPD patients; NCT01937338, an endotoxin challenge study; and NCT02238483, a Phase IIa efficacy study in COPD patients.

Is AZD7624 the same as any other drug?

No alternative names for AZD7624 have been reported. The drug is identified solely by its code name AZD7624 in clinical trial registries and scientific literature. It is a distinct investigational compound developed by AstraZeneca for respiratory conditions.