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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
Sponsor: Alesta Therapeutics
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).
Official title: A Randomised, Placebo Controlled, Double-Blind, Single-Ascending Dose And Multiple-Ascending Dose First-In-Human Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Orally Administered ALE1 With Or Without Food In Healthy Adult Subjects And Adult Patients With Hypophosphatasia
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-09-30
Completion Date
2027-01
Last Updated
2026-01-30
Healthy Volunteers
Yes
Conditions
Interventions
ALE1
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (2)
New Zealand Clinical Research
Grafton, Auckland, New Zealand
Fortrea Clinical Research Unit
Leeds, United Kingdom