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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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See also
Status	Clinical Trial	Phase
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Completed	`NCT03425747` - Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism	Phase 4
Active, not recruiting	`NCT05778071` - Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism	Phase 3
Completed	`NCT05214274` - Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults
Withdrawn	`NCT03878953` - A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism	Phase 3