In short
ALE1 is being studied in clinical trials in healthy adults and adults with hypophosphatasia. The trials are looking at safety, tolerability, how the body handles ALE1, and early signs of its effects to help find suitable doses.
Key points
- ALE1 is being studied in one authorised Phase 1/2 trial. The study includes healthy adults and adults with hypophosphatasia. Researchers are checking safety, tolerability, pharmacokinetics, and pharmacodynamics. The trial uses single and multiple-ascending oral doses to help identify suitable doses of ALE1. The main measured outcome is the number and severity of treatment-emergent adverse events. The planned enrollment is 120 participants.
Trial overview
The clinical trial for ALE1 is an interventional study in healthy adult participants and adult patients with hypophosphatasia. The study is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, and to help identify suitable doses of ALE1.
Who is being studied
This study includes two main groups: healthy adults and adults with hypophosphatasia. Healthy participants help researchers understand how ALE1 behaves in people without the disease, while the patient group helps show what happens in the target condition.
Hypophosphatasia is the condition listed in the trial data, and it is the disease being studied in the patient group. The source data do not list any other conditions or age groups beyond adults.
What researchers are measuring
The main outcome is the number and severity of treatment-emergent adverse events (TEAEs) in healthy participants and patients with hypophosphatasia, with increasing oral doses of ALE1. TEAEs are medical problems that start or become worse after the study treatment begins.
The study also looks at pharmacokinetics and pharmacodynamics. Pharmacokinetics means how the body handles the study treatment, and pharmacodynamics means the early effects seen in the body.
Study design and phase
This is a Phase 1/2 trial. In simple terms, Phase 1/2 studies are early trials that first focus on safety and dose finding, and may also look for early signs of benefit.
The study uses single-ascending dose and multiple-ascending dose oral administration. This means the trial tests one dose first, then higher doses, and also repeated doses over time to learn more about the medicine in the body.
The interventions listed are ALE1 matched placebo and oral ALE1 dose groups, including ALE1 I and ALE1 III. The source data do not explain these dose labels further, so they should be understood only as different study groups in the trial.
Trial status and size
The trial status is Authorised. The planned enrollment is 120 participants.
Because this is an early-stage study, the main purpose is to collect research data that can guide later trials. The key question is whether ALE1 can be studied safely enough, at what doses, and with what early body response in adults with and without hypophosphatasia.