RecruitingPhase 1/2

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

New Zealand, United Kingdom120 participantsStarted 2025-09-30

Plain-language 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).

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants are overtly healthy as determined by a medical evaluation
✓. No concurrent medical conditions or significant medical history, in the opinion of the investigator.

Exclusion criteria

✕. 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

What they're measuring

Evaluate the safety of ALE1 by assessing the number of treatment emergent adverse events (TEAEs)

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants haematology parameters post-dose

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants biochemistry parameters post-dose

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing changes in heart rhythms via electrocardiogram

Timeframe: From baseline up to day 16

Evaluate safety of ALE 1 by assessing the presence of clinically significiant changes in participants vital signs

Timeframe: From baseline up to day 16

Trial details

NCT IDNCT07179640

SponsorAlesta Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Hypophosphatasia (HPP) trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants are overtly healthy as determined by a medical evaluation
✓. No concurrent medical conditions or significant medical history, in the opinion of the investigator.

Exclusion criteria

✕. 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

What they're measuring

Evaluate the safety of ALE1 by assessing the number of treatment emergent adverse events (TEAEs)

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants haematology parameters post-dose

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants biochemistry parameters post-dose

Timeframe: From baseline up to day 16

Evaluate safety of ALE1 by assessing changes in heart rhythms via electrocardiogram

Timeframe: From baseline up to day 16

Evaluate safety of ALE 1 by assessing the presence of clinically significiant changes in participants vital signs

Timeframe: From baseline up to day 16