Recent Updates
Recently added Catalysts

AZD8630 via test inhaler

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 17, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

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.
Healthy ParticipantsUnlock trial analytics

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about AZD8630 via test inhaler

What is AZD8630?

AZD8630 is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. A completed study, NCT06531811, investigated the relative bioavailability of AZD8630 following a device and formulation transition in healthy participants.

What is AZD8630 used for?

AZD8630 is being studied for use in healthy participants. The completed Phase 1 trial, NCT06531811, evaluated the relative bioavailability of AZD8630 following a device and formulation transition. The study enrolled 32 healthy volunteers in the United States.

Who makes AZD8630?

AZD8630 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is an investigational small molecule currently in Phase 1 clinical development.

What phase is AZD8630 in?

AZD8630 is in Phase 1 clinical development. The drug is investigational and not approved. A Phase 1 study, NCT06531811, has been completed, which evaluated the relative bioavailability of AZD8630 following a device and formulation transition in healthy participants.

What clinical trials is AZD8630 in?

AZD8630 has one completed clinical trial, NCT06531811, titled "A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants." This Phase 1 study enrolled 32 healthy participants in the United States.