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ALXN1910

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Feb 27, 2025

ALXN1910 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

ALXN1910 clinical trials

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 drug being developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult participants in the United Kingdom. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing ALXN1910?

ALXN1910 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this small molecule candidate.

What phase is ALXN1910 in?

ALXN1910 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this candidate.

What clinical trials is ALXN1910 in?

ALXN1910 has been evaluated in one completed Phase 1 trial, NCT05307978, titled a Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants. The trial enrolled 48 healthy volunteers in the United Kingdom and used a randomized, double-blind, controlled design.

How many participants were enrolled in the ALXN1910 trial?

The Phase 1 trial of ALXN1910, NCT05307978, enrolled 48 participants. It was a randomized, double-blind, controlled study conducted in healthy volunteers aged 18 years and older in the United Kingdom. The trial has been completed.