A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1
A Randomised, Placebo Controlled, Double-Blind, Single-Ascending Dose And Multiple-Ascending Dose First-In-Human Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Orally Administered ALE1 With Or Without Food In Healthy Adult Subjects And Adult Patients With Hypophosphatasia
Alesta Therapeutics
120 participants
Sep 30, 2025
INTERVENTIONAL
Conditions
Summary
This is a phase 1/2a randomised, placebo controlled, double-blind study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALE1 on healthy adult subjects and adult patients with Hypophosphatasia (HPP).
Eligibility
Inclusion Criteria3
- Participants are overtly healthy as determined by a medical evaluation
- No concurrent medical conditions or significant medical history, in the opinion of the investigator.
- \. Documented ALPL gene variant
Exclusion Criteria6
- \. History of conditions affecting bone or mineral metabolism
- Previous treatment with an enzyme replacement therapy (ERT) or any advanced therapeutic agent (e.g., gene therapy) for the treatment of hypophosphatasia (HPP) or any treatment for osteoporotic diseases
- Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function
- Diagnosis of hyperparathyroidism
- Diagnosis of hypoparathyroidism, unless secondary to HPP
- New fracture within 12 weeks before first dosing
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Interventions
Specified dose on specified days
Specified dose on specified days
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07179640