Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants
NCT ID: NCT05501717
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2022-08-16
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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ALXN2030 Dose A
ALXN2030 will be administered as a single dose.
ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
ALXN2030 Dose B
ALXN2030 will be administered as a single dose.
ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
ALXN2030 Dose C
ALXN2030 will be administered as a single dose.
ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
ALXN2030 Dose D
ALXN2030 will be administered as a single dose.
ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
ALXN2030 Dose E
ALXN2030 will be administered as a single dose.
ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
Placebo
Placebo will be administered as a single dose.
Placebo
Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
Interventions
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ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
Placebo
Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
Eligibility Criteria
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Inclusion Criteria
* QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
* 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 60 years of age.
* BMI within the range 18-32kg/m2 (inclusive) at Screening.
Exclusion Criteria
* Current or relevant history of physical or psychiatric illness.
* Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
* Female participants who are pregnant or breastfeeding.
* Major surgery or hospitalization within 90 days prior to dosing on Day1.
* History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.
18 Years
60 Years
ALL
Yes
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Harrow, , United Kingdom
Countries
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Other Identifiers
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ALXN2030-HV-101
Identifier Type: -
Identifier Source: org_study_id
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