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

Chronic Hypoparathyroidism Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Hypoparathyroidism
• Hypoparathyroidism

• NCT number: NCT05239221
• Study type: Interventional
• Source: Amolyt Pharma
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 7, 2020
• Completion date: August 23, 2022