A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions

A Randomized, Open-label, Parallel, Two-formulation, Single-dose Bioequivalence Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions

The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anemia under fasting condition. The main questions it aims to answer are:

• [Question 1] Is there significant difference in the pharmacokinetic profile between the ferric derisomaltose injection 10mL:1000mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric derisomaltose injection held by Pharmacosmos A/S . (trade name: MonoFer®, strength: 10mL:1000mg [calculated by iron]) )?
• [Question 2] Is it safe for participants with iron deficiency anemia to take ferric derisomaltose injection (10mL:1000mg [calculated by iron])) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of participants with iron deficiency anemia in each group, to receive test product or reference product according to the protocol below.
• Dosing on D1: Group T (Test product) Group R (Reference product)
• Pharmacokinetics(PK) blood sample collection
• Safety evaluation

Inclusion Criteria:

1. Signed the Informed Consent Form(ICF) before the study and fully understood the study content, procedures, and possible adverse reactions;
2. Able to complete the study according to the protocol requirements;
3. The participant or their partner has used effective contraceptive measures within 14 days before screening and promises not to have any pregnancy, sperm donation, or egg donation plans from signing the ICF until 3 months after the last dose, and voluntarily agrees to use effective non-drug contraceptive measures;
4. Male and/or female participants aged ≥18 years (inclusive);
5. Participant weight is not less than 50.0 kg. Body mass index (BMI) = weight (kg) / height2 (m2), with BMI in the range of 18.5-30.0 kg/m2 (inclusive);
6. Confirmed to have iron deficiency anemia at screening, defined as follows (both criteria must be met): ①Hemoglobin (Hb)<110 g/L; ②Serum transferrin saturation ≤20% and serum ferritin ≤100 ng/mL.

Exclusion Criteria:

1. Allergic constitution (e.g., asthma, eczema, etc.), or known allergy to Ferric Derisomaltose Injection or other parenteral iron preparations, maltose or its analogues, metabolites, water for injection, hydrochloric acid or sodium hydroxide, or nitrogen;
2. History of severe or chronic diseases of the circulatory, digestive, respiratory, urinary, hematological, metabolic, immune, or neuropsychiatric systems, or current neoplasm malignant, within 12 months prior to screening, other than iron deficiency anemia, and judged by the investigator as unsuitable for participation in the study;
3. Acute infection within 2 weeks prior to screening;
4. Laboratory tests: alanine aminotransferase (ALT) >1.5 times the upper limit of normal (×ULN); aspartate aminotransferase (AST) > 1.5×ULN; total bilirubin (TBiL) > 1.5×ULN; albumin <30 g/L; platelets <90×109/L; neutrophil count <1.3×109/L; glomerular filtration rate (GFR) <60 ml/min/1.73m2 (estimated by the simplified Modification of Diet in Renal Disease (MDRD) formula, GFR [mL/(min·1.73m2)] = 186 × serum creatinine mg/dL-1.154 × age year-0.203 (×0.742, for females)), or other results from hematology, automated urinalysis, blood chemistry, coagulation profile, iron metabolism, or serum ferritin judged by the investigator as unsuitable for participation in the study;
5. Screening electrocardiogram (ECG) showing severe arrhythmia, including but not limited to: recurrent ventricular tachycardia, highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, supraventricular tachycardia, etc., and judged by the investigator as unsuitable for participation in the study;
6. Presence of iron storage diseases (e.g., hemochromatosis); diseases with impaired iron utilisation (e.g., sideroblastic anemia); hemoglobinopathy (e.g., thalassaemia), decompensated liver function; or symptomatic anemia requiring red blood cell transfusion;
7. Intravenous iron therapy within 3 months prior to screening, erythropoiesis-stimulating agent therapy and/or transfusion history within 4 weeks prior to screening, and use of oral iron or iron-containing preparations within 7 days prior to screening;
8. Use of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal preparations and formulas, etc.) or health supplements that may affect the PK results of this product within 14 days prior to screening;
9. Average daily smoking of more than 5 cigarettes in the 3 months prior to screening;
10. History of surgery within 3 months prior to screening that, in the investigator's judgment, would affect drug absorption, distribution, metabolism, or excretion, or planning to undergo surgery during the study period;
11. Participation in other clinical trials and/or receipt of investigational drugs within 3 months prior to screening;
12. Blood donation or significant blood loss (>400 mL, excluding menstrual blood loss in females) within 3 months prior to screening;
13. Female participants who are breastfeeding or have a positive pregnancy test result during the screening period or clinical study;
14. Positive result for any of the following tests: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody;
15. History of drug abuse within 5 years prior to screening or use of illicit drugs within 3 months prior to screening;
16. Occurrence of an acute illness or use of concomitant medication from the screening phase until before study drug administration;
17. Ingestion of chocolate, any caffeine-containing or xanthine-rich foods or beverages within 48 hours before receiving the study drug;
18. Regular alcohol use within 3 months prior to screening, defined as an average of more than 14 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or unwillingness to stop drinking alcohol or any alcohol-containing products during the study;
19. Positive drug abuse test or alcohol breath screening;
20. Consumption of special diets (e.g., grapefruit and grapefruit-containing products) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion within 48 hours before receiving the study drug;
21. Vaccination within 14 days prior to screening or planning to be vaccinated during the study period;
22. Intolerance to venipuncture or history of needle/blood phobia;
23. Physical examination and vital signs judged by the physician to be clinically significant abnormalities (excluding signs of anemia) or, in the investigator's judgment, other conditions that may increase participant risk or interfere with study assessments or results;
24. Other participants judged by the investigator as unsuitable for participation;
25. Participants who are unable to continue the study for personal reasons.