Study of ALXN1850 in Participants With Hypophosphatasia (HPP)
Study Identifier:
ALXN1850-HPP-101
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Biological: ALXN1850
Date
Sep 2021 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 64 Years
Requirements Information
Inclusion and Exclusion Criteria
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
Sex
Female & Male
Age
18 - 64 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Biological: ALXN1850
Date
Sep 2021 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 64 Years years
Requirements Information
Inclusion and Exclusion Criteria
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
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Las Vegas, Nevada, United States, 89113
Status
N/A
Location
Research Site
Columbus, Ohio, United States, 43203
Status
N/A
Location
Research Site
Nashville, Tennessee, United States, 37232
Status
N/A
Location
Research Site
Austin, Texas, United States, 78744
Status
N/A