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Tests treatment safety and results for Hypophosphatasia (HPP)
Official title 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
ClinicalTrials.gov ID: NCT07179640
What this study is testing
What is ALE1?
ALE1 is an investigational medicine, being studied as a potential treatment for hypophosphatasia (hpp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Key Part 1:
- Participants are overtly healthy as determined by a medical evaluation
- No concurrent medical conditions or significant medical history, in the opinion of the investigator. Key Part 2: 1\. Documented ALPL gene variant Key
You likely can't join if
- Part 1: 1\. History of conditions affecting bone or mineral metabolism Key Exclusion Criteria Part 2:
- Previous treatment with an enzyme replacement therapy (ERT) or any advanced therapeutic agent (e.g., gene therapy) for the treatment of...
- Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve...
- Diagnosis of hyperparathyroidism
- Diagnosis of hypoparathyroidism, unless secondary to HPP
- New fracture within 12 weeks before first dosing
The study team makes the final eligibility decision.
Where it's taking place
- Grafton, Auckland, New Zealand
- Leeds, United Kingdom
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 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grafton, Auckland, New Zealand; Leeds, United Kingdom. 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 ClinicalTrials.gov; the study team decides eligibility.