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 location...
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
New Zealand
New Zealand Clinical Research
RECRUITING
Grafton
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