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Monoclonal Antibodies
ALXN1850 for Hypophosphatasia
Phase 1
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called ALXN1850 to see if it is safe and effective for adults with Hypophosphatasia (HPP). The drug will be given either through a vein or under the skin. Researchers want to understand how the drug moves through the body, its effects, and if it causes any immune reactions. Asfotase alfa (Strensiq™) is a first-in-class bone-targeted human recombinant tissue-nonspecific alkaline phosphatase (TNSALP) replacement therapy approved for treating hypophosphatasia (HPP).
Eligible Conditions
- Hypophosphatasia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ALXN1850Experimental Treatment1 Intervention
Three experimental cohorts will be administered 3 dosages (low, medium, high) of ALXN1850, respectively, via IV infusion and/or SC over multiple administration intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN1850
2021
Completed Phase 1
~20
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Who is running the clinical trial?
AlexionLead Sponsor
246 Previous Clinical Trials
38,614 Total Patients Enrolled
25 Trials studying Hypophosphatasia
1,537 Patients Enrolled for Hypophosphatasia
Alexion Pharmaceuticals, Inc.Lead Sponsor
259 Previous Clinical Trials
140,421 Total Patients Enrolled
25 Trials studying Hypophosphatasia
1,537 Patients Enrolled for Hypophosphatasia
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,700 Total Patients Enrolled
21 Trials studying Hypophosphatasia
1,345 Patients Enrolled for Hypophosphatasia
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