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ALXN1910

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 27, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ALXN1910 · 1 trial · 1 indication

Phase 1 1
NCT05307978Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy ParticipantsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Day 1 (postdose) through Day 75

The safety and tolerability of ALXN1910 was assessed.

Secondary Endpoints

Maximum Observed Serum Concentration (Cmax)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Time to Maximum Observed Serum Concentration (Tmax)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Apparent Terminal Elimination Half Life (t1/2)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParticipants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV.
Cohort 2EXPERIMENTALParticipants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 3EXPERIMENTALParticipant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.
Cohort 4EXPERIMENTALJapanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 5EXPERIMENTALParticipants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.
Cohort 6EXPERIMENTALParticipants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.

Interventions

NameTypeDescription
ALXN1910DRUGParticipants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
PlaceboDRUGParticipants will receive Placebo IV or Placebo SC according to their assigned cohort.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants * Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents). * Participants of Japanese descent must be between 20 and 55 years of age. Exclusion Criteria: * Current or recurrent disease * ...

Countries:United Kingdom
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Frequently asked questions about ALXN1910

What is ALXN1910?

ALXN1910 is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other.

What is ALXN1910 used for?

ALXN1910 is being studied for use in healthy participants. It is an investigational small molecule in Phase 1 clinical development. The drug is not approved for any indication and is still in early-stage clinical trials.

Who makes ALXN1910?

ALXN1910 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of this investigational small molecule.

What phase is ALXN1910 in?

ALXN1910 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The drug has completed one Phase 1 trial in healthy participants.

What clinical trials is ALXN1910 in?

ALXN1910 has one completed clinical trial, NCT05307978, which was a Phase 1 study in healthy participants. The trial, conducted in the United Kingdom, enrolled 48 participants and evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug.

Is ALXN1910 the same as any other drug?

ALXN1910 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being developed by AstraZeneca PLC and is currently in Phase 1 clinical trials.