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

NCT07790562 | Recruiting Phase 1

• 1 other identifier: 2026-BE-YMYTT-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameter of total iron in serum: maximum observed plasma concentration (Cmax)

  Cmax is the peak concentration of total iron in serum. It is directly obtained from observed blood drug concentration-time data.

  -24 hour, -12 hour, and 0 hour, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hour, 1.5 hour, 1.75 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 144 hour, and 168 hour

• Pharmacokinetic parameter of total iron in serum: area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)

  AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.All parameters are baseline-corrected.

  -24 hour, -12 hour, and 0 hour, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hour, 1.5 hour, 1.75 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 144 hour, and 168 hour

• Pharmacokinetic parameter of transferrin bound iron in serum: Cmax

  Cmax is the peak concentration of transferrin bound iron in serum. It is directly obtained from observed blood drug concentration-time data.

  -24 hour, -12 hour, and 0 hour, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hour, 1.5 hour, 1.75 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 144 hour, and 168 hour

• Pharmacokinetic parameter of transferrin bound iron in serum: AUC0-t

  AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.All parameters are baseline-corrected.

  -24 hour, -12 hour, and 0 hour, 10 min, 20 min, 30 min, 45 min, 1 hour, 1.25 hour, 1.5 hour, 1.75 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 144 hour, and 168 hour

Secondary Outcomes (1)

• Adverse Events (AEs) and Serious Adverse Events (SAE)

  On Day 8

Study Arms (2)

Test product-Ferric Derisomaltose Injection provided by Sichuan Huiyu Pharmaceutical Co., Ltd.

EXPERIMENTAL

Drug: Ferric Derisomaltose Injection

Reference product-held by Pharmacosmos A/S

ACTIVE COMPARATOR

Drug: Ferric Derisomaltose Injection [MonoFer®]

Interventions

Ferric Derisomaltose Injection DRUG

For the T group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the test product (T,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).

Test product-Ferric Derisomaltose Injection provided by Sichuan Huiyu Pharmaceutical Co., Ltd.

Ferric Derisomaltose Injection [MonoFer®] DRUG

For the R group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the reference product (trade name: MonoFer®) (R,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).

Reference product-held by Pharmacosmos A/S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the Informed Consent Form(ICF) before the study and fully understood the study content, procedures, and possible adverse reactions;
• Able to complete the study according to the protocol requirements;
• 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;
• Male and/or female participants aged ≥18 years (inclusive);
• 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);
• 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.

You may not qualify if:

• 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;
• 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;
• Acute infection within 2 weeks prior to screening;
• 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;
• 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;
• 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;
• 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;
• 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;
• Average daily smoking of more than 5 cigarettes in the 3 months prior to screening;
• 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;
• Participation in other clinical trials and/or receipt of investigational drugs within 3 months prior to screening;
• Blood donation or significant blood loss (\>400 mL, excluding menstrual blood loss in females) within 3 months prior to screening;
• Female participants who are breastfeeding or have a positive pregnancy test result during the screening period or clinical study;
• 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;
• History of drug abuse within 5 years prior to screening or use of illicit drugs within 3 months prior to screening;

Sponsors & Collaborators

• Sichuan Huiyu Pharmaceutical Co., Ltd: lead
• Suzhou Chenyan Life Science Co., Ltd.: collaborator
• Boji Data Technology (Beijing) Co., Ltd.: collaborator
• Boji Medical Technology Co., Ltd.: collaborator
• Hopeshine-Minsheng Hospital of Xinzheng: collaborator

Study Sites (1)

Hopeshine-Minsheng Hospital of Xinzheng

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ziyun Gan

CONTACT

+8615520826510; ziyun.gan4874@huiyupharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 27, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (1)