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AZD5055

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 8, 2023

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05955183Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..PHASE1 COMPLETED 38Jul 27, 2023Dec 4, 2023Dec 8, 20231 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events
Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).

The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.

Secondary Endpoints
Maximum serum concentration (Cmax)
Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
AZD5055ACTIVE_COMPARATORParticipants will orally receive AZD5055.
PlaceboPLACEBO_COMPARATORParticipants will orally receive placebo.
Interventions
NameTypeDescription
AZD5055DRUGAZD5055 will be given orally to randomized participants as per the arm they are assigned.
PlaceboDRUGPlacebo will be given orally to randomized participants as per the arm they are assigned.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For Chinese subjects only: 1. Participant was born in greater China, including Hong Kong, Macau, and Taiwan. 2. Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview. 3. Participant did not live outside of greater China for mo...

Countries:United States
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