Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults

Inclusion Criteria:

1. An understanding, ability, and willingness to fully comply with study procedures andrestrictions.

2. Ability to voluntarily provide written, signed, and dated informed consent asapplicable to participants in the study.

3. Adult males or females 18 or older (prior to screening). Those < 25 years old willbe examined radiologically (Bone age X-ray of non-dominant wrist and hand) to ensureepiphyseal closure prior to enrollment into the study.

4. Hypoparathyroidism patients, from any etiology, who are on currently availableStandard of Care (SoC) e.g., calcium supplement and active vitamin Dmetabolite/analog.

5. Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake

6. Albumin-adjusted total serum calcium concentration level between 7.5 mg/dL and 10.5mg/dL, or if outside of this range, considered not clinically significant by theInvestigator.

7. Vitamin D metabolite/analog therapy with calcitriol ≥0.25μg QD or alfacalcidol ≥0.50 μg QD.

8. Serum 25-hydroxyvitamin D (25OHD) ≥50 nmol/l (20 ng/ml), or if below, considered notclinically significant by the Investigator.

9. No change of treatment for hypocalcemia over the last 3 months prior to Screening asreported by the patient or through medical documentation, or if a change hasoccurred, it is expected to remain stable, as determined by the Investigator.

10. Absence or stable symptoms from hypocalcemia over the last 3 months prior toScreening as reported by the patient or through medical documentation.

11. For subjects receiving thyroid replacement therapy, the dose is stable for at least 6 weeks prior to screening and the TSH serum levels are within the normal range. Aserum TSH level below the lower limit of the normal range but not undetectable inparticipant treated with thyroid hormone may be allowed if there is no anticipatedneed for a change in thyroid hormone dose during the trial.

12. Female subjects who are postmenopausal (12 consecutive months of spontaneousamenorrhea and age >= 51 years), or who are surgically sterilized may be enrolled,as may women of childbearing potential who had a negative pregnancy test atscreening and are willing to use two medically acceptable methods of contraceptionfor the duration of the study and undergo pregnancy testing according to the studyprotocol.

Exclusion Criteria:

1. Any disease that might affect calcium metabolism or calcium-phosphate homeostasisother than hypoparathyroidism, such as active hyperthyroidism, Paget's disease ofbone, Type 1 or poorly controlled Type 2 diabetes mellitus (HbA1c > 9%), acromegaly,multiple endocrine neoplasia types I and II, Cushing's syndrome or disease, acutepancreatitis, malnutrition, recent prolonged immobility.

2. Severe liver disease (Child-Pugh score >9) (US FDA, 2003) or hepatic transaminases (ALT and AST) > 3 times the upper limit.

3. Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2.

4. Clinical history of symptomatic renal stones within the past 3 months. Subjects withasymptomatic renal stones are permitted.

5. Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiacdisease, ulcerative colitis, and Crohn's disease.

6. Chronic or severe cardiac disease within the past 6 months including but not limitedto heart failure classified as NYHA Class II-IV (Dolgin and NYHA, 1994),uncontrolled arrhythmias, bradycardia (resting heart rate < 48 beats/minute), QTc >450msec (males) or >470 msec (females) on ECG.

7. History of active or untreated malignancy (excluding thyroid cancer or basal cellskin cancer) within the past 2 years. For thyroid cancers, low-riskwell-differentiated thyroid cancer that is stable does not require a disease-freeperiod. High-risk thyroid cancer or uncontrolled cases must be disease-free for atleast 1 year prior to Screening.

8. Seizure disorder/epilepsy with a history of a seizure within the previous 6 monthsprior to screening.

9. Acute gout within 6 months prior to screening.

10. Cerebrovascular accident within 6 months prior to Screening.

11. Subjects dependent on regular parenteral calcium infusions (e.g., calcium gluconate)to maintain calcium homeostasis.

12. Use of prohibited medications within respective prohibited periods prior toscreening such as loop diuretics (30 days), raloxifene hydrochloride (3 months),lithium (30 days), methotrexate at dose >20 mg per week, or systemic corticosteroids (3 months).

13. Thiazide diuretics may be permitted if the dosage has remained stable for threemonths prior to screening, and there is no expected need for a dosage change duringthe trial.

14. Other drugs known to influence calcium and bone metabolism, such as calcitonin,cinacalcet hydrochloride, and fluoride tablets within 3 months prior to screening.

15. Use of oral bisphosphonates within 6 months or IV bisphosphonate preparations within 12 months prior to screening.

16. Previous treatment with PTH/parathyroid hormone-related protein-like drugs,including PTH(1-84) and PTH(1-34) within 30 days prior to screening.

17. Current use of Amorphous Calcium Carbonate (ACC) food supplement.

18. History of diagnosed substance abuse or alcohol dependence within the previous 3years.

19. Pregnant/ breastfeeding patients.