Recruiting

ALE1 Safety and Effects in Healthy Adults and Hypophosphatasia Patients

What is being tested

ALE1

+ Placebo

Drug

Who is being recruted

Hypophosphatasia+4

+ Metabolic Diseases

+ Metabolism, Inborn Errors

From 18 to 50 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorAlesta Therapeutics

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the effects of a new medicine called ALE1, which is taken by mouth, on healthy adults and adults who have a rare condition called Hypophosphatasia (HPP). HPP is a genetic disorder that affects bone development, leading to fragile bones and other health issues. The study seeks to understand how the body processes ALE1, its safety, and how well it is tolerated by participants. The goal is to potentially provide a new treatment option for people with HPP, addressing the current lack of effective therapies for this condition. Participants in this study will be randomly assigned to receive either ALE1 or a placebo, which is a substance with no active medication, in a manner where neither the participants nor the researchers know who receives which treatment. This method helps ensure unbiased results. The study will examine how ALE1 behaves in the body over time and any effects it might have, both immediately and after repeated doses. Participants will be monitored for any side effects to determine the medication's safety and how well it is tolerated with or without food. This careful monitoring helps ensure the safety of all involved while gathering necessary data to evaluate ALE1's potential as a treatment.

Official TitleA 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

Principal SponsorAlesta Therapeutics

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypophosphatasiaMetabolic DiseasesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, Inborn

Criteria

3 inclusion criteria required to participate

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

6 exclusion criteria prevent from participating

History of conditions affecting bone or mineral metabolism

Diagnosis of hyperparathyroidism

Diagnosis of hypoparathyroidism, unless secondary to HPP

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

New Zealand Clinical Research

Grafton, New ZealandOpen New Zealand Clinical Research in Google Maps

Recruiting

Fortrea Clinical Research Unit

Leeds, United Kingdom

Recruiting

2 Study Centers