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

Phase 1

Completed

• Conditions: Chronic Hypoparathyroidism
• Interventions: Drug: Placebo; Drug: AZP-3601

• Registration Number: NCT05239221
• Lead Sponsor: Amolyt Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-14
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Results First Submitted: 2023-08-28
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Results First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Parts A and B)	Placebo	subcutaneous (sc) administration once daily
AZP-3601	AZP-3601	subcutaneous (sc) administration once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum Phosphate - Part B	Day 1, Day 14	Serum phosphate levels (mg/dL) in Part B
Serum Phosphate - Part A	24 hours	Serum phosphate levels (mg/dL) in Part A
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.
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.
Calcium Corrected for Albumin - Part B	24 hours, Day 14	Levels of calcium corrected for albumin (mg/dL) in Part B
Observed Maximum Concentration (Cmax) - Part B	Day 1, Day 14	Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B
Observed Maximum Concentration (Cmax) - Part A	24 hours	Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A
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
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
Calcium Corrected for Albumin - Part A	24 hours	Levels of calcium corrected for albumin (mg/dL) in Part A
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.
Daily Dose of Oral Calcium and Active Vitamin D - Part C	Day 28 and Day 43	Daily dose of oral calcium and active vitamin D for patients treated in Part C.
Serum Phosphate - Part C	Day 1 (H0), Day 14 (H2), Day 28 (H2) and Day 84 (H2)	Serum phosphate levels (mg/dL) in Part C.

Trial Locations

Locations (2)

PRA-EDS; 🇳🇱 Groningen, Netherlands

Amolyt Pharma Investigational Site Hungary; 🇭🇺 Budapest, Hungary