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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
EU CTIS ID: 2025-522378-36-00
What this study is testing
To investigate the safety and tolerability of ALE1 in healthy adult participants and adult patients with HPP following single and multiple-ascending oral dose administrations.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥ 18 to ≤ 65 years (inclusive) at the time of signing the ICF.
- Part 1: 1) Participants are overtly healthy as determined by a medical evaluation.
- Part 1: 2) No concurrent medical conditions or significant medical history, in the opinion of the investigator.
- Part 2: 1) Documented ALPL gene variant.
You likely can't join if
- Part 1: History of conditions affecting bone or mineral metabolism.
- Part 2: 1) Previous treatment with an enzyme replacement therapy (ERT) or any advanced therapeutic agent (e.g., gene therapy) for the treatment of HPP or any treatment for osteoporotic diseases.
- Part 2: 2) Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function.
- Part 2: 3) Diagnosis of hyperparathyroidism.
- Part 2: 4) Diagnosis of hypoparathyroidism, unless secondary to HPP.
- Part 2: 5) New fracture within 12 weeks before first dosing.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.