Can a new iron injection match the standard treatment?
NCT ID NCT07790562
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether a new version of ferric derisomaltose, an intravenous iron treatment, works the same as the approved product MonoFer in people with iron deficiency anemia. About 88 participants will receive a single dose of either the test or reference injection after fasting. Researchers will compare how much iron enters the blood and monitor for side effects to see if the new formulation is a viable alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ferric derisomaltose injection (an intravenous iron replacement)
- What this could lead to
- If the new formulation matches the reference in how the body absorbs it, it could become an approved, more accessible treatment option for iron deficiency anemia in China.
- What could go wrong
- This is an early-phase study focused on comparing drug levels, not on proving long-term benefit. The new version might not perform identically to the reference, and safety data is limited to a single dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Iron deficiency anemia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hopeshine-Minsheng Hospital of Xinzheng
RECRUITINGZhengzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One infusion before surgery: could it cut transfusions?
- Iron and folic acid: a simple pill that could ease anemia and heart symptoms?
- A simple nutrient may shield Babies' brains from iron deficiency
- Could heart failure drugs boost oral Iron's power against anemia?
- Iron pills every other day? new trial tests a gentler approach for anemia in pregnancy
- App and chat combo takes on anemia in teen girls