Trials Sponsors Conditions Drugs Pricing

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 InjectionDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Suzhou Chenyan Life Science Co., Ltd.
Type not reportedcollaborator
Boji Data Technology (Beijing) Co., Ltd.
Type not reportedcollaborator

Study Sites (1)

Hopeshine-Minsheng Hospital of Xinzheng

Zhengzhou, China

RECRUITING

Jinxi ChenCONTACT+86 13849056696 chenjinxi6688@126.com

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional 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

Actual (reported)

Primary Completion

September 29, 2026

Actual (reported)

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;
+10 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (2)

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

Reference product-held by Pharmacosmos A/S

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (2)

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

Reference product-held by Pharmacosmos A/S

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations