Trials / Recruiting
RecruitingNCT07179640
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Alesta Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALE1 | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2025-09-18
- Last updated
- 2026-01-30
Locations
2 sites across 2 countries: New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT07179640. Inclusion in this directory is not an endorsement.