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

Key Inclusion Criteria Part 1:

• Participants are overtly healthy as determined by a medical evaluation
• No concurrent medical conditions or significant medical history, in the opinion of the investigator.

Key Inclusion Criteria Part 2:

• Documented ALPL gene variant

Key Exclusion Criteria Part 1:

• History of conditions affecting bone or mineral metabolism

Key Exclusion Criteria Part 2:

• Previous treatment with an enzyme replacement therapy (ERT) or any advanced therapeutic agent (e.g., gene therapy) for the treatment of hypophosphatasia (HPP) or any treatment for osteoporotic diseases
• Previous exposure to any medication or investigational agent potentially affecting bone structure, muscle volume, muscle strength, or muscle or nerve function
• Diagnosis of hyperparathyroidism
• Diagnosis of hypoparathyroidism, unless secondary to HPP
• New fracture within 12 weeks before first dosing