Clinical Trials in the UK / NCT07179640
Recruiting
Phase 1/2
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
NCT07179640 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Hypophosphatasia (HPP)
Investigational drug(s) / intervention(s)
ALE1Placebo
ALE1: Specified dose on specified days
Placebo: Specified dose on specified days
Study 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
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
Primary outcome measure(s)
- Evaluate the safety of ALE1 by assessing the number of treatment emergent adverse events (TEAEs) — From baseline up to day 16
- Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants haematology parameters post-dose — From baseline up to day 16
- Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants biochemistry parameters post-dose — From baseline up to day 16
- Evaluate safety of ALE1 by assessing changes in heart rhythms via electrocardiogram — From baseline up to day 16
- Evaluate safety of ALE 1 by assessing the presence of clinically significiant changes in participants vital signs — From baseline up to day 16
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitätsklinikum Würzburg | Würzburg | Germany | Recruiting |
| New Zealand Clinical Research | Grafton | Auckland | Recruiting |
| Fortrea Clinical Research Unit | Leeds | United Kingdom | Recruiting |
Other trials for the same condition
Registry of Patients With Hypophosphatasia
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07179640 on ClinicalTrials.gov ↗ ← All trials in the UK