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| Name | Class |
|---|---|
| Amolyt Pharma | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZP-3601 | Experimental | subcutaneous (sc) administration once daily |
|
| Placebo (Parts A and B) | Placebo Comparator | subcutaneous (sc) administration once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZP-3601 | Drug | Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Maximum Concentration (Cmax) - Part A | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A | 24 hours |
| Observed Maximum Concentration (Cmax) - Part B | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium Excretion Rate 24h- Part C | 24 hour calcium excretion rate (mg/24h) in Part C. | Day 1, Day 14, Day 28 and Day 84 |
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:
Main exclusion criteria
Parts A and B:
Part C:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amolyt Pharma Investigational Site Hungary | Budapest | Hungary | ||||
| PRA-EDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40423237 | Derived | Ovize M, Allas S, Culler MD, Milano S, Ouldrouis T, Sumeray M, van de Wetering de Rooij J, Mannstadt M. Phase 1 clinical trial of eneboparatide, a novel PTH receptor 1 agonist. Endocr Connect. 2025 Jun 19;14(6):e240464. doi: 10.1530/EC-24-0464. Print 2025 Jun 1. |
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A total of 132 subjects were enrolled in the study. Of those, 52 subjects were enrolled in Part A (Phase 1), 52 subjects were enrolled in Part B (Phase 1), and 28 subjects were enrolled in Part C (Phase 2a).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A (Cohort A1, 5 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1. |
| FG001 | Part A (Cohort A2, 10 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1. |
| FG002 | Part A (Cohort A3, 20 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1. |
| FG003 | Part A (Cohort A4, 40 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1. |
| FG004 | Part A (Cohort A5, 60 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1. |
| FG005 | Part A (Cohort A6, 120 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1. |
| FG006 | Part A (Cohort A7, 90 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1. |
| FG007 | Part A (Placebo) | Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1. |
| FG008 | Part B (Cohort B1, 10 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| FG009 | Part B (Cohort B2, 20 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| FG010 | Part B (Cohort B3, 40 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| FG011 | Part B (Cohort B4, 60 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| FG012 | Part B (Cohort B5, 80 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| FG013 | Part B (Placebo) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14. |
| FG014 | Part C (Cohort C1, Starting Dose of 20 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
| FG015 | Part C (Cohort C2, Starting Dose of 10 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (Cohort A1, 5 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1. |
| BG001 | Part A (Cohort A2, 10 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (TEAEs) | Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25). | Posted | Count of Participants | Participants | Up to 2 weeks in Part A and Part B, and up to 3 months in Part C |
|
Up to 2 weeks (Part A and Part B) and up to 3 months (Part C)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A (Cohort A1, 5 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 5ug of AZP-3601 on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior VP of Clinical Development and Regulatory Affairs | Amolyt Pharma | +33 428 01 21 54 | contact@amolyt.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2022 | Aug 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2022 | Aug 25, 2023 | SAP_001.pdf |
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Part C is open label
| Placebo | Drug | Saline solution visually matching active medication |
|
| Day 1, Day 14 |
| Observed Maximum Concentration (Cmax) - Part C | 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 | 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 | 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 | 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 | Levels of calcium corrected for albumin (mg/dL) in Part A | 24 hours |
| Calcium Corrected for Albumin - Part B | Levels of calcium corrected for albumin (mg/dL) in Part B | 24 hours, Day 14 |
| Calcium Corrected for Albumin - Part C | Levels of calcium corrected for albumin (mg/dL) in Part C. | Day 1, Day 14, Day 28 and Day 84 |
| Serum Phosphate - Part A | Serum phosphate levels (mg/dL) in Part A | 24 hours |
| Serum Phosphate - Part B | Serum phosphate levels (mg/dL) in Part B | Day 1, Day 14 |
| Serum Phosphate - Part C | 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 | Daily dose of oral calcium and active vitamin D for patients treated in Part C. | Day 28 and Day 43 |
| Groningen |
| 9728 |
| Netherlands |
| Withdrawal by Subject |
|
| BG002 | Part A (Cohort A3, 20 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1. |
| BG003 | Part A (Cohort A4, 40 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1. |
| BG004 | Part A (Cohort A5, 60 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1. |
| BG005 | Part A (Cohort A6, 120 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1. |
| BG006 | Part A (Cohort A7, 90 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1. |
| BG007 | Part A (Placebo) | Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1. |
| BG008 | Part B (Cohort B1, 10 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| BG009 | Part B (Cohort B2, 20 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| BG010 | Part B (Cohort B3, 40 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| BG011 | Part B (Cohort B4, 60 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| BG012 | Part B (Cohort B5, 80 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| BG013 | Part B (Placebo) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14. |
| BG014 | Part C (Cohort C1, Starting Dose of 20 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
| BG015 | Part C (Cohort C2, Starting Dose of 10 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
| BG016 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1. |
| OG003 | Part A (Cohort A4, 40 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1. |
| OG004 | Part A (Cohort A5, 60 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1. |
| OG005 | Part A (Cohort A6, 120 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1. |
| OG006 | Part A (Cohort A7, 90 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1. |
| OG007 | Part A (Placebo) | Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1. |
| OG008 | Part B (Cohort B1, 10 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| OG009 | Part B (Cohort B2, 20 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| OG010 | Part B (Cohort B3, 40 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| OG011 | Part B (Cohort B4, 60 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| OG012 | Part B (Cohort B5, 80 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14. |
| OG013 | Part B (Placebo) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14. |
| OG014 | Part C (Cohort C1, Starting Dose of 20 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
| OG015 | Part C (Cohort C2, Starting Dose of 10 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards. |
|
|
| Secondary | Observed Maximum Concentration (Cmax) - Part A | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
|
|
| Secondary | Observed Maximum Concentration (Cmax) - Part B | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B | Data not collected for a few subjects (missing data or site error) | Posted | Mean | Standard Deviation | pg/mL | Day 1, Day 14 |
|
|
|
| Secondary | Observed Maximum Concentration (Cmax) - Part C | Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part C. | 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. | Posted | Mean | Standard Deviation | pg/mL | Day 1, Day 14, Day 28, Day 84 |
|
|
|
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part A | Area under the plasma-drug concentration time curve (AUC) (pg*h/mL) in Part A | Posted | Mean | Standard Deviation | pg*h/mL | 24 hours |
|
|
|
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part B | Area Under the Plasma-drug Concentration Time Curve (AUC) (pg*h/mL) in Part B | Data not collected for a few subjects (missing data or site error). | Posted | Mean | Standard Deviation | pg*h/mL | Day 1, Day 14 |
|
|
|
| Secondary | Area Under the Plasma-drug Concentration Time Curve (AUC) - Part C | Area Under the Plasma-drug Concentration Time Curve (AUC) (pg*h/mL) in Part C. | 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. | Posted | Mean | Standard Deviation | pg*h/mL | Day 1, Day 14, Day 28, Day 84 |
|
|
|
| Secondary | Calcium Corrected for Albumin - Part A | Levels of calcium corrected for albumin (mg/dL) in Part A | Posted | Mean | Standard Deviation | mg/dL | 24 hours |
|
|
|
| Secondary | Calcium Corrected for Albumin - Part B | Levels of calcium corrected for albumin (mg/dL) in Part B | One (1) subject in Cohort B4 discontinued from the study. | Posted | Mean | Standard Deviation | mg/dL | 24 hours, Day 14 |
|
|
|
| Secondary | Calcium Corrected for Albumin - Part C | Levels of calcium corrected for albumin (mg/dL) in Part C. | 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). | Posted | Mean | Standard Deviation | mg/dL | Day 1, Day 14, Day 28 and Day 84 |
|
|
|
| Secondary | Serum Phosphate - Part A | Serum phosphate levels (mg/dL) in Part A | Posted | Mean | Standard Deviation | mg/dL | 24 hours |
|
|
|
| Secondary | Serum Phosphate - Part B | Serum phosphate levels (mg/dL) in Part B | One (1) subject in Cohort B4 discontinued from the study. | Posted | Mean | Standard Deviation | mg/dL | Day 1, Day 14 |
|
|
|
| Secondary | Serum Phosphate - Part C | Serum phosphate levels (mg/dL) in Part C. | 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). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error). | Posted | Mean | Standard Deviation | mg/dL | Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2) |
|
|
|
| Secondary | Daily Dose of Oral Calcium and Active Vitamin D - Part C | Daily dose of oral calcium and active vitamin D for patients treated in Part C. |
| Posted | Count of Participants | Participants | Day 28 and Day 43 |
|
|
|
| Other Pre-specified | Calcium Excretion Rate 24h- Part C | 24 hour calcium excretion rate (mg/24h) in Part C. | 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). For this reason, data was collected in ten (10) subjects in Cohort 1 and fourteen (14) subjects in Cohort 2 on Day 84. In addition, data not collected for a few subjects (missing data or site error). | Posted | Mean | Standard Deviation | mg/24h | Day 1, Day 14, Day 28 and Day 84 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Part A (Cohort A2, 10 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 10 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Part A (Cohort A3, 20 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 20 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part A (Cohort A4, 40 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 40 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part A (Cohort A5, 60 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 60 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Part A (Cohort A6, 120 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 120 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Part A (Cohort A7, 90 ug Dose) | Healthy volunteers were administered a single subcutaneous (SC) dose of 90 ug of AZP-3601 on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | Part A (Placebo) | Healthy volunteers were administered a single, subcutaneous dose of placebo on Day 1. | 0 | 13 | 0 | 13 | 8 | 13 |
| EG008 | Part B (Cohort B1, 10 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 10 ug of AZP-3601, once daily, from Day 1 to Day 14. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG009 | Part B (Cohort B2, 20 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 20 ug of AZP-3601, once daily, from Day 1 to Day 14. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG010 | Part B (Cohort B3, 40 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 40 ug of AZP-3601, once daily, from Day 1 to Day 14. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG011 | Part B (Cohort B4, 60 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 60 ug of AZP-3601, once daily, from Day 1 to Day 14. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG012 | Part B (Cohort B5, 80 ug Doses) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of 80 ug of AZP-3601, once daily, from Day 1 to Day 14. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG013 | Part B (Placebo) | Healthy volunteers were administered a multiple subcutaneous (SC) doses of placebo, once daily, from Day 1 to Day 14. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG014 | Part C (Cohort C1, Starting Dose of 20 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 20 ug/day, and up-titration of the dose was allowed from Day 14 onwards. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG015 | Part C (Cohort C2, Starting Dose of 10 ug/Day) | Patients with hypoparathyroidism were treated with a once daily subcutaneous doses of AZP-3601 from Day 1 to Day 84. The starting dose was 10 ug/day, and up-titration of the dose was allowed from Day 14 onwards. | 0 | 16 | 0 | 16 | 12 | 16 |
| Motion Sickness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Otorrhea | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Asthenophenia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Bowel Movement Irregularity | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal Sounds Abdominal | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Administration site hematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA | Non-systematic Assessment |
|
| application site pruritis | General disorders | MedDRA | Non-systematic Assessment |
|
| asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Catheter site hematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Catheter site irritation | General disorders | MedDRA | Non-systematic Assessment |
|
| Catheter Site Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Catheter Site Swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA | Non-systematic Assessment |
|
| Hunger | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Hematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Pruritis | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral Swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Puncture site erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Odema Peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA | Non-systematic Assessment |
|
| Vessel puncture site hematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Vessel puncture site reaction | General disorders | MedDRA | Non-systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Urine calcium/creatine ratio increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Vitamin D increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypoasthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Hypercalciuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Sensitive Skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
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| Day 14 |
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| Day 14 |
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| Day 28 |
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| Day 84 |
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| Day 14 |
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| Day 14 |
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| Day 28 |
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| Day 84 |
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| Day 14 |
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| Day 14 |
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| Day 28 |
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| Day 84 |
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| Day 14 |
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| Day 14 |
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| Day 28 |
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| Day 84 |
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| Number of patients taking =< 500 mg/day of calcium on Day 84 |
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| Number of patients taking no vitamin D on Day 28 |
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| Number of patients taking no vitamin D on Day 84 |
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| Day 14 |
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| Day 28 |
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| Day 84 |
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