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

September 4, 2025 updated by: Alexion Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Amolyt Pharma Investigational Site Hungary
  • Netherlands
      • Groningen, Netherlands, 9728
        • PRA-EDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Main inclusion criteria

  • Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2
  • Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2

  • Part C:

    1. Male and female patients aged 18 to 75 years inclusive
    2. History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH).
    3. Requirement for therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day (both are active vitamin D supplements), and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above normal dietary calcium intake at baseline assessments.

Main exclusion criteria

  • Parts A and B:

    1. Clinically significant abnormal lab values, as judged by the investigator
    2. Using tobacco products with 3 months prior to first drug administration
    3. History of alcohol abuse or drug addiction

  • Part C:

    1. Known history of autosomal-dominant hypocalcemia (ADH resulting from gain-of-function calcium-sensing receptor [CaSR] or GNA11 mutations) or pseudohypoparathyroidism (impaired responsiveness to PTH)
    2. Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP
    3. Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides (e.g., digoxin or digitoxin) or systemic corticosteroids within 4 weeks prior to start of treatment.
    4. Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZP-3601
subcutaneous (sc) administration once daily
Drug: AZP-3601
Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection
Other Names:
  • eneboparatide
Placebo Comparator: Placebo (Parts A and B)
subcutaneous (sc) administration once daily
Drug: Placebo
Saline solution visually matching active medication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 weeks in Part A and Part B, and up to 3 months in Part C
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
Up to 2 weeks in Part A and Part B, and up to 3 months in Part C

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Observed Maximum Concentration (Cmax) - Part A
Time Frame: 24 hours
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A
24 hours
Observed Maximum Concentration (Cmax) - Part B
Time Frame: Day 1, Day 14
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B
Day 1, Day 14
Observed Maximum Concentration (Cmax) - Part C
Time Frame: Day 1, Day 14, Day 28, Day 84
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part C.
Day 1, Day 14, Day 28, Day 84
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A
Time Frame: 24 hours
Area under the plasma-drug concentration time curve (AUC) (pg*h/mL) in Part A
24 hours
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B
Time Frame: Day 1, Day 14
Area Under the Plasma-drug Concentration Time Curve (AUC) (pg*h/mL) in Part B
Day 1, Day 14
Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C
Time Frame: Day 1, Day 14, Day 28, Day 84
Area Under the Plasma-drug Concentration Time Curve (AUC) (pg*h/mL) in Part C.
Day 1, Day 14, Day 28, Day 84
Calcium Corrected for Albumin - Part A
Time Frame: 24 hours
Levels of calcium corrected for albumin (mg/dL) in Part A
24 hours
Calcium Corrected for Albumin - Part B
Time Frame: 24 hours, Day 14
Levels of calcium corrected for albumin (mg/dL) in Part B
24 hours, Day 14
Calcium Corrected for Albumin - Part C
Time Frame: Day 1, Day 14, Day 28 and Day 84
Levels of calcium corrected for albumin (mg/dL) in Part C.
Day 1, Day 14, Day 28 and Day 84
Serum Phosphate - Part A
Time Frame: 24 hours
Serum phosphate levels (mg/dL) in Part A
24 hours
Serum Phosphate - Part B
Time Frame: Day 1, Day 14
Serum phosphate levels (mg/dL) in Part B
Day 1, Day 14
Serum Phosphate - Part C
Time Frame: Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2)
Serum phosphate levels (mg/dL) in Part C.
Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2)
Daily Dose of Oral Calcium and Active Vitamin D - Part C
Time Frame: Day 28 and Day 43
Daily dose of oral calcium and active vitamin D for patients treated in Part C.
Day 28 and Day 43

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Calcium Excretion Rate 24h- Part C
Time Frame: Day 1, Day 14, Day 28 and Day 84
24 hour calcium excretion rate (mg/24h) in Part C.
Day 1, Day 14, Day 28 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amolyt Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AZP-3601-CLI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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