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RECRUITING
NCT07179640
PHASE1/PHASE2

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

Sponsor: Alesta Therapeutics

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-30

Completion Date

2027-01

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

DRUG

ALE1

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Locations (2)

New Zealand Clinical Research

Grafton, Auckland, New Zealand

Fortrea Clinical Research Unit

Leeds, United Kingdom