A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E

Inclusion criteria

• Healthy males or non-pregnant, non-lactating healthy females.
• Aged 18 to 55 years, inclusive, at the time of signing informed consent.
• 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.
• Must be willing and able to comply with all study requirements including dietary requirements.
• Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements
• Must agree to use an adequate method of contraception.
• Alkaline phosphatase level within standard reference range/normal limits at screening and admission.
• Serum inorganic phosphate level within standard reference range/normal limits at screening and admission.
• Serum parathyroid hormone (PTH) level within standard reference range/normal limits at screening.
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within reference range/normal limits at screening and admission.

Exclusion criteria

• 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.
• Subjects who are study site or Sponsor employees, or subjects who are immediate family members of study site or Sponsor employees.
• Subjects who have previously been administered IMP in this study.
• History of any drug or alcohol abuse in the past 2 years prior to screening.
• Regular alcohol consumption in 6 months prior to screening.
• A confirmed positive alcohol urine test at screening or admission.
• 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.
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening.
• Females of childbearing potential must have a negative pregnancy test (urine pregnancy test at screening). Females who are pregnant or lactating will be excluded.
• Have poor venous access that limits phlebotomy.
• Clinically significant abnormal clinical chemistry or hematology as judged by the Investigator.
• Clinically significant abnormal urinalysis as judged by the Investigator.
• History of diabetes mellitus (types I or II).
• Prediabetes (fasting blood sugar level of >106 (repeat x 1 for confirmation of abnormal level).
• Hypertriglyceridemia (fasting triglyceride level of > 200 mg/dL) at screening.
• Subjects who, in the Investigator's opinion, have a clinically significant abnormal 12-lead resting ECG.
• Positive drugs of abuse test result.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
• Evidence of renal impairment at screening, as indicated by an eGFR < 90mL/min/m^2.
• 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.
• History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
• History of hypophosphatasia.
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
• Significant serious active skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
• 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.
• 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.
• 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.
• Failure to satisfy the Investigator of fitness to participate for any other reason.
• Known hypersensitivity to egg, soya or peanut proteins.
• Food allergies deemed clinically relevant by the investigator which would hinder ability to adhere to the prescribed diet.