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ALXN2050

Phase 1

Renal Impairment | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: Sep 29, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04623710Study of ALXN2050 in Participants With Renal ImpairmentPHASE1 COMPLETED 40 — — Jul 8, 2021Mar 21, 2022Sep 29, 20232 United States
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Study Endpoints
Primary Endpoints
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Up to 72 hours postdose
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Up to 72 hours postdose
Maximum (Peak) Steady-state Plasma Concentration (Cmax,ss) Of Plasma ALXN2050
Up to 72 hours postdose
Time To Reach Maximum (Peak) Plasma Concentration Following ALXN2050 Administration At Steady-state (Tmax,ss)
Up to 72 hours postdose
Secondary Endpoints
Change From Baseline In Complement Factor D Concentration At 24, 48, And 72 Hours Postdose
Baseline, 24, 48, and 72 hours postdose
Change From Baseline In Plasma b Fragment Of Complement Factor B Concentration
Baseline, up to 72 hours postdose
Change From Baseline In Complement Alternative Pathway Activity
Baseline, up to 72 hours postdose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1: Severe Impaired Renal FunctionEXPERIMENTALParticipants will receive ALXN2050.
Cohort 2: Moderate Impaired Renal FunctionEXPERIMENTALParticipants will receive ALXN2050.
Cohort 3: Mild Impaired Renal FunctionEXPERIMENTALParticipants will receive ALXN2050.
Cohort 4: Healthy ControlEXPERIMENTALParticipants will receive ALXN2050.
Interventions
NameTypeDescription
ALXN2050DRUGALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Body weight must be at least 50.0 kilograms (kg) and body mass index (BMI) within the range of 18.0 - 40.0 kg/meter squared (m\^2) (inclusive) at the time of signing the informed consent. 2. Contraceptive use by men or women should be consistent with local regulations regardi...

Countries:United States
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