Trial · NCT05239221
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
NCT05239221, Phase 1, Phase 2, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2024-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism. Trials, record NCT05239221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05239221
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
- NCT number
- NCT05239221
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 132 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Chronic Hypoparathyroidism
- Interventions
- AZP-3601, Placebo
- First posted
- 2022-02-14
- Last updated
- 2025-09-08
- Results first posted
- 2024-01-31
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (TEAEs) | 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). |
| Secondary | Observed Maximum Concentration (Cmax) - Part A | 24 hours | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A |
| Secondary | Observed Maximum Concentration (Cmax) - Part B | Day 1, Day 14 | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B |
| Secondary | Observed Maximum Concentration (Cmax) - Part C | Day 1, Day 14, Day 28, Day 84 | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part C. |
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A | 24 hours | Area under the plasma-drug concentration time curve (AUC) (pg\*h/mL) in Part A |
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B | Day 1, Day 14 | Area Under the Plasma-drug Concentration Time Curve (AUC) (pg\*h/mL) in Part B |
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C | Day 1, Day 14, Day 28, Day 84 | Area Under the Plasma-drug Concentration Time Curve (AUC) (pg\*h/mL) in Part C. |
| Secondary | Calcium Corrected for Albumin - Part A | 24 hours | Levels of calcium corrected for albumin (mg/dL) in Part A |
| Secondary | Calcium Corrected for Albumin - Part B | 24 hours, Day 14 | Levels of calcium corrected for albumin (mg/dL) in Part B |
| Secondary | Calcium Corrected for Albumin - Part C | Day 1, Day 14, Day 28 and Day 84 | Levels of calcium corrected for albumin (mg/dL) in Part C. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Emergent Adverse Events (TEAEs) | Up to 2 weeks in Part A and Part B, and up to 3 months in Part C | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part A | 24 hours | pg/mL | MEAN | |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part B | Day 1, Day 14 | Data not collected for a few subjects (missing data or site error) | pg/mL | MEAN |
| SECONDARY | Observed Maximum Concentration (Cmax) - Part C | Day 1, Day 14, Day 28, Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). PK data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84. | pg/mL | MEAN |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A | 24 hours | pg*h/mL | MEAN | |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B | Day 1, Day 14 | Data not collected for a few subjects (missing data or site error). | pg*h/mL | MEAN |
| SECONDARY | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C | Day 1, Day 14, Day 28, Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). Pharmacokinetic (PK) data was not collected in Cohort 1 on Day 84 per the protocol at the time. The protocol was updated following completion of Cohort 1 to collect PK information in Cohort 2 on Day 84. | pg*h/mL | MEAN |
| SECONDARY | Calcium Corrected for Albumin - Part A | 24 hours | mg/dL | MEAN | |
| SECONDARY | Calcium Corrected for Albumin - Part B | 24 hours, Day 14 | One (1) subject in Cohort B4 discontinued from the study. | mg/dL | MEAN |
| SECONDARY | Calcium Corrected for Albumin - Part C | Day 1, Day 14, Day 28 and Day 84 | One (1) subject dropped out in Cohort 2 prior to the extension phase. In addition to this subject, two (2) subjects from Cohort 1 and one (1) subject from Cohort 2 did not participate in the extension phase (data on Day 84). In addition, data not collected for a few subjects (missing data or site error). | mg/dL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A1, 5 ug Dose) | 2 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A2, 10 ug Dose) | 3 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A3, 20 ug Dose) | 5 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A4, 40 ug Dose) | 1 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A5, 60 ug Dose) | 3 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A6, 120 ug Dose) | 6 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Cohort A7, 90 ug Dose) | 6 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part A (Placebo) | 8 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part B (Cohort B1, 10 ug Doses) | 6 | Participants | ||
| Treatment Emergent Adverse Events (TEAEs) | Part B (Cohort B2, 20 ug Doses) | 7 | Participants |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A (Cohort A1, 5 ug Dose) | 3 | |
| Overall Study | STARTED | Part A (Cohort A2, 10 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Cohort A3, 20 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Cohort A4, 40 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Cohort A5, 60 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Cohort A6, 120 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Cohort A7, 90 ug Dose) | 6 | |
| Overall Study | STARTED | Part A (Placebo) | 13 | |
| Overall Study | STARTED | Part B (Cohort B1, 10 ug Doses) | 8 | |
| Overall Study | STARTED | Part B (Cohort B2, 20 ug Doses) | 8 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,488
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Part A (Cohort A1, 5 ug Dose) | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A2, 10 ug Dose) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A3, 20 ug Dose) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A4, 40 ug Dose) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A5, 60 ug Dose) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A6, 120 ug Dose) | 1 | 6 | 1 |
| other | Palpitations | Cardiac disorders | Part A (Cohort A7, 90 ug Dose) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Part A (Placebo) | 1 | 13 | 1 |
| other | Palpitations | Cardiac disorders | Part B (Cohort B1, 10 ug Doses) | 0 | 8 | 0 |
| other | Palpitations | Cardiac disorders | Part B (Cohort B2, 20 ug Doses) | 1 | 8 | 1 |
1 to 10 of 1,488Source ClinicalTrials.gov
See all 1,488 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A (Cohort A1, 5 ug Dose) | 0 | 3 |
| Total, all-cause mortality | Part A (Cohort A2, 10 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Cohort A3, 20 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Cohort A4, 40 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Cohort A5, 60 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Cohort A6, 120 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Cohort A7, 90 ug Dose) | 0 | 6 |
| Total, all-cause mortality | Part A (Placebo) | 0 | 13 |
| Total, all-cause mortality | Part B (Cohort B1, 10 ug Doses) | 0 | 8 |
| Total, all-cause mortality | Part B (Cohort B2, 20 ug Doses) | 0 | 8 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40423237 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05239221
GET https://conductscience.org/api/trials/v1/NCT05239221/results?page=2