Status:
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
Lead Sponsor:
Alesta Therapeutics
Conditions:
Hypophosphatasia (HPP)
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 patie...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria 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 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:
- 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
- Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function
- Diagnosis of hyperparathyroidism
- Diagnosis of hypoparathyroidism, unless secondary to HPP
- New fracture within 12 weeks before first dosing
Exclusion
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07179640
Start Date
September 30 2025
End Date
January 1 2027
Last Update
December 1 2025
Active Locations (1)
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1
New Zealand Clinical Research
Grafton, Auckland, New Zealand, 1010