Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04999527
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2021-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2021-08-07', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 71 days of monitoring'}, {'measure': 'Incidence of abnormal laboratory test results', 'timeFrame': 'Up to 71 days of monitoring'}, {'measure': 'Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)', 'timeFrame': 'Up to 71 days of monitoring'}, {'measure': 'Incidence of treatment-emergent clinically abnormal physical exam', 'timeFrame': 'Up to 71 days of monitoring'}], 'secondaryOutcomes': [{'measure': 'Plasma maximum measured drug concentration (Cmax)', 'timeFrame': 'Up to 71 days of testing'}, {'measure': 'Time of maximum concentration (Tmax)', 'timeFrame': 'Up to 71 days of testing'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'Up to 71 days of testing'}, {'measure': 'Plasma half-life (T½)', 'timeFrame': 'Up to 71 days of testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '38515275', 'type': 'DERIVED', 'citation': 'Novikov N, Buch A, Yang H, Andruk M, Liu G, Wu M, Howell H, MacDonald B, Savage W. First-in-Human Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of DISC-0974, an Anti-Hemojuvelin Antibody, in Healthy Participants. J Clin Pharmacol. 2024 Aug;64(8):953-962. doi: 10.1002/jcph.2432. Epub 2024 Mar 21.'}], 'seeAlsoLinks': [{'url': 'https://www.discmedicine.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female (HV only) adults aged 18 to 65 years, inclusive at the time of consent.\n* Body weight ≥50 kg and body mass index (BMI) between 18 and 33, inclusive, at Screening.\n* Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 at Screening.\n* No clinically significant abnormalities as determined by medical history, by results of physical examination, vital signs, ECG and lab tests at Screening.\n* QTcF \\<450 msec at Screening.\n* Estimated glomerular filtration rate \\>60 mL/min/1.73m2 based on the 4 parameter MDRD (Modification of Diet in Renal Disease) equation at Screening\n* TSAT ≤30% at Screening, as determined in a fasting morning blood sample (06:00 to 11:00 hours).\n* 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.\n* 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\n* If female, postmenopausal, as defined with at least 12 months natural, spontaneous amenorrhea, or at least 6 weeks following surgical menopause\n* Able to understand and provide written informed consent and comply with protocol requirements\n\nExclusion Criteria:\n\n* History of anemia or hematologic disorder within 1 year of Screening\n* History of splenectomy\n* Diagnosis or first-degree relative with a diagnosis of hemochromatosis\n* History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease\n* Vegan or iron-deficient diet within 3 months of Screening\n* Blood transfusion within 1 year of Screening\n* Whole blood donation within 6 months of Screening or plasma donation within 30 days of Screening.\n* A history of alcohol or illicit drug use disorder within 3 years of Screening, as assessed by the Investigator\n* Use of any tobacco- and/or nicotine-containing containing products, including e-cigarettes, vaping products, and nicotine replacement products, within 3 months of Screening\n* Use of multivitamin or iron supplements within 30 days prior to Screening\n* ALT or aspartate aminotransferase (AST) level above the normal range at Screening\n* Positive urine pregnancy test at Screening or Baseline (Day -1).\n* Positive serologic test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening.\n* Positive urine screen for drugs of abuse or alcohol test on admission to the study center\n* 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.\n* History of a major surgical procedure within 60 days of Screening or planned surgical procedure within 90 days of dosing.\n* A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04999527', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Disc Medicine, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DISC-0974-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteer: Single Ascending Dose of DISC-0974', 'description': 'Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers', 'interventionNames': ['Drug: DISC-0974']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteer: Single Ascending Dose of Placebo', 'description': 'Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DISC-0974', 'type': 'DRUG', 'description': 'DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose', 'armGroupLabels': ['Healthy Volunteer: Single Ascending Dose of DISC-0974']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose', 'armGroupLabels': ['Healthy Volunteer: Single Ascending Dose of Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'William Savage, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Disc Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Disc Medicine, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}