CompletedPhase 1/2

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

Hungary, Netherlands132 participantsStarted 2020-09-07

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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
✕. 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.

What they're measuring

Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to 2 weeks in Part A and Part B, and up to 3 months in Part C

Trial details

NCT IDNCT05239221

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-23

Results submitted2023-08-28

View on ClinicalTrials.gov More Chronic Hypoparathyroidism trials