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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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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