Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
34 participants
INTERVENTIONAL
2021-03-17
2022-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1: ALXN1830 Single Dose 1/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Cohort 2: ALXN1830 Single Dose 2/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Cohort 3: ALXN1830 Multiple Dose 1/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Cohort 4: ALXN1830 Multiple Dose 2/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Cohort 5: ALXN1830 Multiple Dose 3/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Cohort 6: ALXN1830 /Placebo in Japanese Population
Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.
ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Interventions
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ALXN1830
ALXN1830 will be administered as SC infusion(s).
Placebo
Placebo will be administered as SC infusion(s).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have had vaccination against pneumococcus (Pneumovax 23 \[PPSV23\]) at least 28 days, and maximally 4 years prior to Day 1.
* Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
* Body weight within 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
* Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.
Exclusion Criteria
* Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
* Participants who have prior exposure to ALXN1830.
* Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
* Participants with hepatitis B or C, or human immunodeficiency virus.
* Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies.
18 Years
55 Years
ALL
Yes
Sponsors
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Syneos Health
OTHER
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Auckland, , New Zealand
Research Site
Grafton, , New Zealand
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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ALXN1830-HV-108
Identifier Type: -
Identifier Source: org_study_id
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