Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04999527
Eligibility Criteria:
Inclusion Criteria:
* Male or female (HV only) adults aged 18 to 65 years, inclusive at the time of consent.
* Body weight ≥50 kg and body mass index (BMI) between 18 and 33, inclusive, at Screening.
* Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 at Screening.
* No clinically significant abnormalities as determined by medical history, by results of physical examination, vital signs, ECG and lab tests at Screening.
* QTcF \<450 msec at Screening.
* Estimated glomerular filtration rate \>60 mL/min/1.73m2 based on the 4 parameter MDRD (Modification of Diet in Renal Disease) equation at Screening
* TSAT ≤30% at Screening, as determined in a fasting morning blood sample (06:00 to 11:00 hours).
* Hematologic parameters (red blood cell count \[RBC\], hemoglobin, hematocrit, platelet count, mean corpuscular volume, mean corpuscular hemoglobin concentration), serum iron, and TIBC within normal range and serum ferritin (within normal range and ≥30 ng/mL) at Screening.
* If a male with female sexual partner(s) of childbearing potential, must agree to use acceptable methods of birth control during the study and through the End of Study (EOS) visit
* If female, postmenopausal, as defined with at least 12 months natural, spontaneous amenorrhea, or at least 6 weeks following surgical menopause
* Able to understand and provide written informed consent and comply with protocol requirements
Exclusion Criteria:
* History of anemia or hematologic disorder within 1 year of Screening
* History of splenectomy
* Diagnosis or first-degree relative with a diagnosis of hemochromatosis
* History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease
* Vegan or iron-deficient diet within 3 months of Screening
* Blood transfusion within 1 year of Screening
* Whole blood donation within 6 months of Screening or plasma donation within 30 days of Screening.
* A history of alcohol or illicit drug use disorder within 3 years of Screening, as assessed by the Investigator
* Use of any tobacco- and/or nicotine-containing containing products, including e-cigarettes, vaping products, and nicotine replacement products, within 3 months of Screening
* Use of multivitamin or iron supplements within 30 days prior to Screening
* ALT or aspartate aminotransferase (AST) level above the normal range at Screening
* Positive urine pregnancy test at Screening or Baseline (Day -1).
* Positive serologic test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening.
* Positive urine screen for drugs of abuse or alcohol test on admission to the study center
* Use of any systemic prescription medication within 14 days of Screening, non-iron containing dietary supplements, or non-prescription drugs within 7 days of dosing.
* History of a major surgical procedure within 60 days of Screening or planned surgical procedure within 90 days of dosing.
* A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.
* History or presence or any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04999527
Study Brief:
Protocol Section:
NCT04999527