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AZD8630 via test inhaler

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Oct 17, 2024

AZD8630 via test inhaler target and mechanism

ModalitySmall molecule

Also known as AZD8630 (test formulation) via test inhaler

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

AZD8630 via test inhaler clinical trials

AZD8630 via test inhaler · 1 trial · 1 indication

Phase 1 1
NCT06531811A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.Healthy Participants
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.
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Study Endpoints

Primary Endpoints

Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose
From Baseline Day 1 to Day 11

To evaluate the relative bioavailability of AZD8630 test device compared to AZD8630 Monodose device.

Secondary Endpoints

Maximum observed plama (peak) drug concentration (Cmax)
From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to infinity (AUCinf)
From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast)
From Baseline Day 1 to Day 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1 (Treatment A- Treatment B)EXPERIMENTALParticipants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder)
Sequence 2 (Treatment B- Treatment A)EXPERIMENTALParticipants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder)

Interventions

NameTypeDescription
AZD8630 (test formulation) via test inhalerDRUGParticipants will receive AZD8630 via test inhaler.
AZD8630 (reference formulation) via Monodose inhalerDRUGParticipants will receive AZD8630 via Monodose inhaler.
Test inhalerDEVICEParticipants will receive AZD8630 via test inhaler.
Monodose inhalerDEVICEParticipants will receive AZD8630 via Monodose inhaler.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy participants aged 18-55 years with suitable veins for cannulation or repeated venipuncture. * Females participants of childbearing potential must not be lactating and, if ...

Countries:United States
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Frequently asked questions about AZD8630 via test inhaler

What is AZD8630 via test inhaler?

AZD8630 via test inhaler is an investigational small molecule drug candidate developed by AstraZeneca PLC (ticker AZN). It is delivered by inhalation and has been studied in a Phase 1 clinical trial in healthy participants. The specific therapeutic indication for this asset has not been disclosed.

Who makes AZD8630 via test inhaler?

AZD8630 via test inhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this inhaled small molecule formulation.

What phase is AZD8630 via test inhaler in?

AZD8630 via test inhaler is in Phase 1 development. It is an investigational drug candidate and is not approved for any indication. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is AZD8630 via test inhaler in?

AZD8630 via test inhaler has been evaluated in one completed Phase 1 trial, NCT06531811, titled a study to investigate the relative bioavailability of AZD8630 following a device and formulation transition in healthy participants. The trial enrolled 32 healthy volunteers in the United States and was randomized and controlled.

Is AZD8630 via test inhaler the same as AZD8630 (test formulation) via test inhaler?

Yes. AZD8630 via test inhaler is also known as AZD8630 (test formulation) via test inhaler. Both names refer to the same AstraZeneca inhaled small molecule drug candidate studied in the completed Phase 1 trial NCT06531811.

What was studied in the AZD8630 via test inhaler trial?

The completed Phase 1 trial NCT06531811 studied the relative bioavailability of AZD8630 following a device and formulation transition in healthy participants. It enrolled 32 participants aged 18 years and older in the United States, was randomized and controlled, and did not use a double-blind design.