A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)

Eligibility Criteria

• 1. Healthy males or non-pregnant, non-lactating healthy females.
• 2. Aged 18 to 55 years, inclusive, at the time of signing informed consent.
• 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 and a minimum body weight of 57 kg as measured at screening.
• 4. Must be willing and able to comply with all study requirements including dietary requirements.
• 5. Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements
• 6. Must agree to use an adequate method of contraception.
• 7. Alkaline phosphatase level within standard reference range/normal limits at screening and admission.
• 8. Serum inorganic phosphate level within standard reference range/normal limits at screening and admission.
• 9. Serum parathyroid hormone (PTH) level within standard reference range/normal limits at screening.
• 10. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within reference range/normal limits at screening and admission.
• 1. Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose, whichever is longer.
• 2. Subjects who are study site or Sponsor employees, or subjects who are immediate family members of study site or Sponsor employees.
• 3. Subjects who have previously been administered IMP in this study.
• 4. History of any drug or alcohol abuse in the past 2 years prior to screening.
• 5. Regular alcohol consumption in 6 months prior to screening.
• 6. A confirmed positive alcohol urine test at screening or admission.
• 7. Current smokers or those who have smoked within the last 12 months prior to screening. A confirmed positive urine cotinine test at screening or first admission.
• 8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening.
• 9. Females of childbearing potential must have a negative pregnancy test (urine pregnancy test at screening). Females who are pregnant or lactating will be excluded.
• 10. Have poor venous access that limits phlebotomy.
• 11. Clinically significant abnormal clinical chemistry or hematology as judged by the Investigator.
• 12. Clinically significant abnormal urinalysis as judged by the Investigator.
• 13. History of diabetes mellitus (types I or II).
• 14. Prediabetes (fasting blood sugar level of \>106 (repeat x 1 for confirmation of abnormal level).
• 15. Hypertriglyceridemia (fasting triglyceride level of \> 200 mg/dL) at screening.
• 16. Subjects who, in the Investigator's opinion, have a clinically significant abnormal 12-lead resting ECG.
• 17. Positive drugs of abuse test result.
• 18. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
• 19. Evidence of renal impairment at screening, as indicated by an eGFR \< 90mL/min/m\^2.
• 20. History of any active systemic or immunologic disease, including but not limited to active renal, hepatic, hematological, gastrointestinal (except appendectomies/cholecystectomy), endocrinal, pulmonary (including asthma), cardiovascular, neurologic, or neurological disease (including demyelinating diseases such as multiple sclerosis), hypertension, tuberculosis, or systemic fungal infection.
• 21. History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
• 22. History of hypophosphatasia.
• 23. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• 24. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
• 25. Significant serious active skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
• 26. Donation or loss of 1 pint of blood within 3 months, or donation of plasma within 7 days prior to first dose of study medication or had a transfusion of any blood product within 3 months prior to study drug administration.
• 27. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT/hormonal contraception) within the last 30 days or five half-lives (whichever is longer), before IMP administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the Investigator.
• 28. Subjects who have been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the Investigator or who have received a recent (as determined by the Investigator) live or attenuated vaccination (with exception of a COVID-19 vaccine or flu vaccine), or exposure to communicable viral diseases such as chicken pox, varicella, and measles.
• 29. Failure to satisfy the Investigator of fitness to participate for any other reason.
• 30. Known hypersensitivity to egg, soy or peanut proteins.
• 31. Food allergies deemed clinically relevant by the investigator which would hinder ability to adhere to the prescribed diet.