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AZD8630 via test inhaler

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06531811A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.PHASE1 COMPLETED 32 — — Aug 6, 2024Oct 3, 2024Oct 17, 20241 United States
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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 — 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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