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

NCT05239221 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-09-08

Study results available
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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

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

Sponsors & Collaborators

  • Amolyt Pharma

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2022-08-23
Completion
2022-08-23
FDA Drug
Yes

Countries

  • Hungary
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05239221 on ClinicalTrials.gov