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

Exclusion Criteria

• •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.