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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• Participants are overtly healthy as determined by a medical evaluation
• No concurrent medical conditions or significant medical history, in the opinion of the investigator.
⁃ 1\. Documented ALPL gene variant
Locations
Other Locations
Germany
Universitätsklinikum Würzburg
RECRUITING
Würzburg
New Zealand
New Zealand Clinical Research
RECRUITING
Grafton
United Kingdom
Fortrea Clinical Research Unit
RECRUITING
Leeds
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2027-01
Participants
Target number of participants: 120
Treatments
Experimental: Part 1 Cohort A
Experimental: Part 1 Cohort B
Experimental: Part 2 Cohort A
Experimental: Part 2 Cohort B
Experimental: Part 1 Cohort C
Related Therapeutic Areas
Sponsors
Leads: Alesta Therapeutics