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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


Study Design

Related Conditions & MeSH terms

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

See also
  Status Clinical Trial Phase
Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
Completed NCT03425747 - Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism Phase 4
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Withdrawn NCT03878953 - A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism Phase 3