Healthy Volunteer
Conditions
Brief summary
This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
Detailed description
Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo. Samples will be collected to measure how DISC-0974 is processed by the body and how the body responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day 1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.
Interventions
DRUGDISC-0974
DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose
DRUGPlacebo
Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose
Sponsors
Disc Medicine, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent clinically abnormal physical exam | Up to 71 days of monitoring |
| Incidence of adverse events | Up to 71 days of monitoring |
| Incidence of abnormal laboratory test results | Up to 71 days of monitoring |
| Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG) | Up to 71 days of monitoring |
Secondary
| Measure | Time frame |
|---|---|
| Plasma maximum measured drug concentration (Cmax) | Up to 71 days of testing |
| Time of maximum concentration (Tmax) | Up to 71 days of testing |
| Area under the concentration-time curve (AUC) | Up to 71 days of testing |
| Plasma half-life (T½) | Up to 71 days of testing |
Countries
United States
Outcome results
None listed