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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT07179640•Alesta Therapeutics

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participants are overtly healthy as determined by a medical evaluation
•2. No concurrent medical conditions or significant medical history, in the opinion of the investigator.
•1\. Documented ALPL gene variant

Exclusion Criteria

•1\. History of conditions affecting bone or mineral metabolism
•1. 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
•2. Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function
•3. Diagnosis of hyperparathyroidism
•4. Diagnosis of hypoparathyroidism, unless secondary to HPP
•5. New fracture within 12 weeks before first dosing

Locations (2)

New Zealand Clinical Research

Grafton, Auckland, New Zealand

Fortrea Clinical Research Unit

Leeds, United Kingdom

Key Dates

Start Date

September 30, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

January 30, 2026

Enrollment

120

ESTIMATED participants

Conditions

Hypophosphatasia (HPP)

Interventions

ALE1

DRUG

Placebo

DRUG

Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)

NCT04181164

Hypophosphatasia (HPP)

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COMPLETEDPHASE2

Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)

NCT00952484

Hypophosphatasia (HPP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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