Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects Following Dose-Escalating Single Intravenous or Subcutaneous Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999527
• Other study ID #: DISC-0974-101
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Disc Medicine, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• DISC-0974
DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose
• Placebo
Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Disc Medicine, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 71 days of monitoring
Primary	Incidence of abnormal laboratory test results		Up to 71 days of monitoring
Primary	Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)		Up to 71 days of monitoring
Primary	Incidence of treatment-emergent clinically abnormal physical exam		Up to 71 days of monitoring
Secondary	Plasma maximum measured drug concentration (Cmax)		Up to 71 days of testing
Secondary	Time of maximum concentration (Tmax)		Up to 71 days of testing
Secondary	Area under the concentration-time curve (AUC)		Up to 71 days of testing
Secondary	Plasma half-life (T½)		Up to 71 days of testing

External Links

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