AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Study Identifier:
AZP-3601-CLI-001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: AZP-3601
- Drug: Placebo
Date
Sep 2020 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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:
- Male and female patients aged 18 to 75 years inclusive
- History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH).
- 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:
- Clinically significant abnormal lab values, as judged by the investigator
- Using tobacco products with 3 months prior to first drug administration
- History of alcohol abuse or drug addiction
- Part C:
- 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)
- Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP
- 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.
- Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.
Sex
Female & Male
Age
18 - 75 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: AZP-3601
- Drug: Placebo
Date
Sep 2020 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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:
- Male and female patients aged 18 to 75 years inclusive
- History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH).
- 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:
- Clinically significant abnormal lab values, as judged by the investigator
- Using tobacco products with 3 months prior to first drug administration
- History of alcohol abuse or drug addiction
- Part C:
- 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)
- Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP
- 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.
- Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.
Protocol 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.
Trial Locations
Location
Status
Location
Amolyt Pharma Investigational Site Hungary
Budapest, Hungary
Status
N/A
Location
PRA-EDS
Groningen, Netherlands, 9728
Status
N/A