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This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer: Single Ascending Dose of DISC-0974 | Experimental | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
|
| Healthy Volunteer: Single Ascending Dose of Placebo | Experimental | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DISC-0974 | Drug | DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Incidence of treatment-emergent clinically abnormal physical exam | Up to 71 days of monitoring |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Savage, MD, PhD | Disc Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38515275 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Drug | Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose |
|
| Up to 71 days of testing |
| Plasma half-life (T½) | Up to 71 days of testing |