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ALXN2050 Prototype

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jun 6, 2024

ALXN2050 Prototype target and mechanism

ModalitySmall molecule

Also known as ALXN2050 MR Prototype Tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

ALXN2050 Prototype clinical trials

ALXN2050 Prototype · 1 trial · 1 indication

Phase 1 1
NCT05780645A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult ParticipantsHealthy Participants
COMPLETED80 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Up to 96 hours postdose
Time to Reach Cmax (Tmax) of ALXN2050
Up to 96 hours postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
Up to 96 hours postdose

Secondary Endpoints

Number of Participants With Adverse Events (AEs)
Day 1 up to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALRegimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions. Optional Regimens C, D, E, and F
Cohort 2EXPERIMENTALRegimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions. Optional Regimens: I, J, K, and L

Interventions

NameTypeDescription
ALXN2050 MR Prototype TabletDRUGParticipants will receive various doses of the MR Prototype Tablet orally.
ALXN2050 Immediate Release (IR) TabletDRUGParticipants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
ALXN2050 MR Prototype Mini-TabletDRUGParticipants will receive various doses of the MR Prototype Mini-Tablet orally.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematolog...

Countries:United Kingdom
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Frequently asked questions about ALXN2050 Prototype

What is ALXN2050 Prototype?

ALXN2050 Prototype is an investigational small molecule developed by AstraZeneca PLC. It is a modified release prototype tablet formulation studied in healthy adult participants, not in patients with a specific disease. The program is in Phase 1 clinical development, and no therapeutic indication has been disclosed for this prototype formulation.

Who is developing ALXN2050 Prototype?

ALXN2050 Prototype is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical study evaluating this modified release prototype tablet formulation.

What phase is ALXN2050 Prototype in?

ALXN2050 Prototype is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory authority. The single Phase 1 study of this prototype has been completed.

What clinical trials is ALXN2050 Prototype in?

ALXN2050 Prototype has been studied in one Phase 1 trial, NCT05780645, titled a study to investigate the pharmacokinetic profile of ALXN2050 modified release prototype formulations and immediate release reference tablet in healthy adult participants. The trial enrolled 80 healthy adults in the United Kingdom and is now completed.

Is ALXN2050 Prototype the same as ALXN2050 MR Prototype Tablet?

Yes. ALXN2050 Prototype is also known as ALXN2050 MR Prototype Tablet. Both names refer to the same modified release prototype tablet formulation developed by AstraZeneca PLC, so readers searching under either name are looking at the same investigational asset.

How was the ALXN2050 Prototype trial designed?

Trial NCT05780645 was a controlled, randomized Phase 1 study of ALXN2050 modified release prototype formulations and an immediate release reference tablet in healthy adult participants. It enrolled 80 participants of all sexes, aged 18 years and older, at sites in the United Kingdom, and it has been completed.