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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

RecruitingPhase 1, Phase 2Ages 18 Years - 50 YearsAllAlesta Therapeutics
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria Part 1: 1. Participants are overtly healthy as determined by a medical evaluation 2. No concurrent medical conditions or significant medical history, in the opinion of the investigator. Key Inclusion Criteria Part 2: 1\. Documented ALPL gene variant Key Exclusion Criteria Part 1: 1\. History of conditions affecting bone or mineral metabolism Key Exclusion Criteria Part 2: 1. 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 2. Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function 3. Diagnosis of hyperparathyroidism 4. Diagnosis of hypoparathyroidism, unless secondary to HPP 5. New fracture within 12 weeks before first dosing
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What it tests

  • ALE1
  • Placebo
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Where

3 sites
Universitätsklinikum Würzburg
Würzburg, Germany
New Zealand Clinical Research
Grafton, New Zealand
Fortrea Clinical Research Unit
Leeds, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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