ClinicalTrials.gov record NCT07179640

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 50 years old
SexAll
LocationGermany, New Zealand, United Kingdom
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, placebo‑controlled, double‑blind early‑phase study evaluates oral ALE1 in healthy adults and adults with hypophosphatasia (HPP). The study uses single‑ascending and multiple‑ascending dose groups and includes assessments with and without food. It measures safety, tolerability, drug levels in the body, and drug effects on biomarkers.

What it is studying. The study is testing the safety and tolerability of orally given ALE1, measuring how the body absorbs and clears the drug (pharmacokinetics), and how the drug affects biological markers (pharmacodynamics), to help identify suitable dose levels and assess the effect of food.

What the researchers hope to learn. Scientific goals: to evaluate safety and tolerability of ALE1, measure its pharmacokinetics and pharmacodynamics, determine dose‑related behavior, and assess the effect of food on drug levels. These data are intended to identify suitable doses for future studies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • ALE1
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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:
  • Documented ALPL gene variant
  • Key

Exclusion criteria

  • Part 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized (blinded) to receive oral ALE1 or placebo in single-ascending and multiple-ascending dose groups, with some dosing evaluated with or without food. They will receive one or more study doses and undergo safety monitoring including vital signs, electrocardiograms (ECGs), and blood tests, plus blood sampling for pharmacokinetic and pharmacodynamic measurements. Assessments and safety checks are performed through about 16 days after dosing. The study team will record any side effects and other safety data.

How the study is structured. An early-phase, randomized, placebo‑controlled, double‑blind trial. Adults are assigned to ALE1 or matching placebo in parallel groups. The study includes dose‑escalation with single and multiple doses and measures safety, vital signs, heart rhythm, blood tests, drug levels, and biomarkers over about 16 days after dosing.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Germany, New Zealand, United Kingdom. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hypophosphatasia

Clinical trials9 trials listed for hypophosphatasiaEvery trial the registry lists for hypophosphatasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hypophosphatasia researchLatest monthly update: September 2026. Includes: Early lab flag. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 30, 2025
Primary completion
January 2027 (estimated)
Study completion
January 2027 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
Aug 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Alesta Therapeutics

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
randomised
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
placebo controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
double-blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamics
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
investigational agent
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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