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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Amolyt Pharma Investigational Site Hungary
Budapest, Hungary
PRA-EDS
Groningen, Netherlands
Treatment Emergent Adverse Events (TEAEs)
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
Time frame: Up to 2 weeks in Part A and Part B, and up to 3 months in Part C
Observed Maximum Concentration (Cmax) - Part A
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part A
Time frame: 24 hours
Observed Maximum Concentration (Cmax) - Part B
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part B
Time frame: Day 1, Day 14
Observed Maximum Concentration (Cmax) - Part C
Observed maximum concentration (Cmax) of AZP-3601 (pg/mL) in Part C.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 1, Day 14, Day 28, Day 84
Calcium Corrected for Albumin - Part A
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Levels of calcium corrected for albumin (mg/dL) in Part A
Time frame: 24 hours
Calcium Corrected for Albumin - Part B
Levels of calcium corrected for albumin (mg/dL) in Part B
Time frame: 24 hours, Day 14
Calcium Corrected for Albumin - Part C
Levels of calcium corrected for albumin (mg/dL) in Part C.
Time frame: Day 1, Day 14, Day 28 and Day 84
Serum Phosphate - Part A
Serum phosphate levels (mg/dL) in Part A
Time frame: 24 hours
Serum Phosphate - Part B
Serum phosphate levels (mg/dL) in Part B
Time frame: Day 1, Day 14
Serum Phosphate - Part C
Serum phosphate levels (mg/dL) in Part C.
Time frame: 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.
Time frame: Day 28 and Day 43