NCT05239221

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

A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZP-3601, a Synthetic Parathyroid Hormone Analog, in Healthy Subjects and in Subjects With Hypoparathyroidism

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	AZP-3601	Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection
DRUG	Placebo	Saline solution visually matching active medication

Timeline

• Start date: 2020-09-07
• Primary completion: 2022-08-23
• Completion: 2022-08-23
• First posted: 2022-02-14
• Last updated: 2025-09-08
• Results posted: 2024-01-31

Locations

2 sites across 2 countries: Hungary, Netherlands

Regulatory

• FDA-regulated drug study