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AZD1402

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 21, 2019

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

AZD1402 · 1 trial · 1 indication

Phase 1 1
NCT03921268Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402Asthma
COMPLETED18 Analytics
PHASE1COMPLETED
Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under serum concentration-time curve from zero to infinity [AUC]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the pharmacokinetics (PK) profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Area under the serum concentration-time curve from zero to infinity divided by dose [AUC/D]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Area under the serum concentration-curve from time zero to time of last quantifiable concentration [AUClast]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration divided by dose [AUClast/D]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Maximum observed serum concentration [Cmax]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Observed maximum serum concentration divided by the dose administered [Cmax/D]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Time to reach maximum observed serum concentration [tmax]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Terminal elimination rate constant [λz]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve [t½z]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Mean residence time of the unchanged drug in the systemic circulation from zero to infinity [MRT]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Apparent total body clearance of drug from serum after extravascular administration [CL/F]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Apparent volume of distribution during the terminal phase after extravascular administration [Vz/F]
Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose

To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.

Secondary Endpoints

Number of patients with adverse events
Spontaneous plus Day 1: Pre-dose and 3 and 12 hours post-dose, Day 2: 24 hours post-dose, Day 3: 48 hours post-dose
Number of patients with abnormal findings in vital signs
Day 1: Pre-dose and 10 minutes post-dose
Number of patients with abnormal electrocardiograms
Day 1: pre-dose and 5 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALDose A estimated delivered single dose of AZD1402 nebuliser solution administered via a nebuliser.
Treatment BEXPERIMENTALDose B estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler.
Treatment CEXPERIMENTALDose C estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler.

Interventions

NameTypeDescription
AZD1402DRUGAZD1402 (PRS-060) is presented as a solution and dry powder for oral inhalation and belongs to a new class of therapeutics, Anticalin® proteins, which are modified lipocalins. AZD1402 is an inhaled IL-4Rα antagonist, which is being developed as controller therapy for asthma.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test ...

Countries:United Kingdom
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Frequently asked questions about AZD1402

What is AZD1402 used for?

AZD1402 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to assess its pharmacokinetics, or how the body processes the medication, in patients with asthma.

Who makes AZD1402?

AZD1402 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational asthma treatment.

What phase is AZD1402 in?

AZD1402 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of asthma.

What clinical trials is AZD1402 in?

AZD1402 has been studied in one completed Phase 1 clinical trial registered as NCT03921268. This trial, titled 'Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402', enrolled 18 participants with asthma in the United Kingdom. The study was controlled but not double-blinded.

Is AZD1402 FDA approved?

AZD1402 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for asthma. The completed Phase 1 trial focused on pharmacokinetics, and the drug has not yet progressed to later-stage trials or received regulatory approval.