Actively Recruiting
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
Led by Alesta Therapeutics · Updated on 2026-01-30
120
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of conditions affecting bone or mineral metabolism
- Previous treatment with enzyme replacement therapy or advanced therapies (e.g., gene therapy) for HPP or treatments for osteoporotic diseases
- Previous exposure to medications or investigational agents affecting bone structure, muscle volume, strength, or nerve function
- Diagnosis of hyperparathyroidism
- Diagnosis of hypoparathyroidism unless secondary to HPP
- New fracture within 12 weeks before first dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New Zealand Clinical Research
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
2
Fortrea Clinical Research Unit
Leeds, United Kingdom
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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