Can a new iron injection match the standard treatment?

NCT ID NCT07790562

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hopeshine-Minsheng Hospital of Xinzheng

    RECRUITING

    Zhengzhou, China

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