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
Recruiting
Phase 1
Phase 2
Interventional Study
Hypophosphatasia (HPP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 50
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Alesta Therapeutics · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria Part 1:
1. Participants are overtly healthy as determined by a medical evaluation
2. No concurrent medical conditions or significant medical history, in the opinion of the investigator.
Key Inclusion Criteria Part 2:
1\. Documented ALPL gene variant
Key Exclusion Criteria …
Contacts
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