Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
NCT ID: NCT05751642
Last Updated: 2024-11-27
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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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2023-04-19
2023-12-04
Brief Summary
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Detailed Description
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Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the discretion of the Investigator, up to 3 more participants will be added at least 48 hours after the dosing of the sentinel pair, followed by dosing of the remaining participants in the cohort no earlier than 72 hours after sentinel pair dosing.
The study will comprise:
A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit) of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day 29.
Each participant will be involved in the study for approximately 56 days.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Cohort 1
Participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.
Cohort 2
Participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.
Cohort 3
Participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.
Cohort 4
Participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.
Cohort 5
Participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
Cohort 6: Japanese Cohort
Japanese participants will receive a single dose of ALXN1920.
ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.
Pooled Placebo
Participants will receive Placebo.
Placebo
Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.
Interventions
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ALXN1920
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.
Placebo
Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.
ALXN1920
Participants will receive a single dose of ALXN1920 by SC infusion.
ALXN1920
Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
* Body mass index within 18.0 to 32.0 kg/m\^2 (inclusive), with a minimum body weight of 50.0 kg.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
* For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.
Exclusion Criteria
* History of significant allergic reaction.
* History of any Neisseria infection
* Active systemic bacterial, viral, or fungal infection.
* Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
* Any major surgery within 8 weeks of Screening.
* Known or suspected history of drug or alcohol abuse.
* Current tobacco users or smokers.
* Positive Human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C viral infection.
* Female participant who are pregnant, breastfeeding, or intending to conceive during the course of the study.
18 Years
55 Years
ALL
Yes
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Grafton, Auckland, New Zealand
Research Site
Christchurch, , New Zealand
Countries
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Other Identifiers
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ALXN1920-HV-101
Identifier Type: -
Identifier Source: org_study_id