AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism

Summary

This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of AZP-3601 following single and repeated administration in both healthy volunteers and patients with chronic hypoparathyroidism (cHP) The protocol includes 3 parts: * Part A: first-in-human single ascending dose (SAD) study in healthy volunteers * Part B: multiple ascending dose (MAD) study with 2 weeks of treatment in healthy volunteers * Part C: open-label MAD study with a total treatment duration of 3 months in patients with cHP.

Timeline

Start

2020-09-07

Primary completion

2022-08-23

Completion

2022-08-23

Publications

• Ovize M, Allas S, Culler MD, Milano S, Ouldrouis T, Sumeray M, van de Wetering de Rooij J, Mannstadt M. Phase 1 clinical trial of eneboparatide, a novel PTH receptor 1 agonist. Endocr Connect. 2025 Jun 19;14(6):e240464. doi: 10.1530/EC-24-0464. Print 2025 Jun 1.

Drugs

Indications