CompletedPhase 1

Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

United States15 participantsStarted 2021-09-28

Plain-language summary

This is an open-label, dose-escalating study to assess safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of ALXN1850 when given intravenous (IV) and subcutaneous (SC) to adults with HPP.

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed clinical diagnosis of HPP * 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: * Primary or secondary hyperparathyroidism or hypoparathyroidism * 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

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: Day 1 up to Day 85

Trial details

NCT IDNCT04980248

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-24

Results submitted2024-07-26

View on ClinicalTrials.gov More Hypophosphatasia trials