Study of ALXN1850 in Participants With Hypophosphatasia (HPP)
NCT ID: NCT04980248
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2021-09-28
2022-08-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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ALXN1850
Three experimental cohorts will be administered 3 dosages (low, medium, high) of ALXN1850, respectively, via IV infusion and/or SC over multiple administration intervals.
ALXN1850
ALXN1850 will be administered as an IV infusion and via the SC route.
Interventions
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ALXN1850
ALXN1850 will be administered as an IV infusion and via the SC route.
Eligibility Criteria
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Inclusion Criteria
* Not anticipated to require further treatment with enzyme replacement therapy to treat participant's HPP after study completion
* Willing and able to follow protocol-specified contraception requirements
* Willing and able to give informed consent
Exclusion Criteria
* Fracture within 12 weeks of screening
* Current or relevant history of unstable physical or psychiatric illness
* Significant allergies
* Asfotase alfa use within 6 months and/or positive for asfotase alfa antidrug antibody/neutralizing antibodies
18 Years
64 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Las Vegas, Nevada, United States
Research Site
Columbus, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Countries
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References
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Dahir KM, Shannon A, Dunn D, Voegtli W, Dong Q, Hasan J, Pradhan R, Pelto R, Pan WJ. Safety, pharmacokinetics, and pharmacodynamics of efzimfotase alfa, a second-generation enzyme replacement therapy: phase 1, dose-escalation study in adults with hypophosphatasia. J Bone Miner Res. 2024 Sep 26;39(10):1412-1423. doi: 10.1093/jbmr/zjae128.
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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ALXN1850-HPP-101
Identifier Type: -
Identifier Source: org_study_id