Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia
Study Details
Study Description
Brief Summary
This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 1b Dose Escalation Single ascending dose of DISC-0974 |
Drug: DISC-0974
DISC-0974 is administered subcutaneously
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo is administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events [up to 8 weeks]
- Incidence of clinically abnormal vital signs [up to 8 weeks]
- Incidence of abnormal laboratory test results [up to 8 weeks]
- Incidence of clinically abnormal physical exam [up to 8 weeks]
- Incidence of clinically abnormal electrocardiograms [up to 8 weeks]
Secondary Outcome Measures
- Change from baseline in concentration of iron laboratory parameter [up to 8 weeks]
- Change from baseline in concentration of hematologic laboratory parameters [up to 8 weeks]
- Cmax-Maximum drug concentration measured in plasma [up to 8 weeks]
- Tmax-Time of maximum drug concentration [up to 8 weeks]
- AUC-Area under the drug concentration time curve [up to 8 weeks]
- T½ - Elimination half life of the drug [up to 8 weeks]
- CL/F-Apparent drug clearance [up to 8 weeks]
- Vd/F-Apparent volume of distribution of the drug [up to 8 weeks]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Aged from 18-75 years of age, inclusive, at the time of signing informed consent.
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Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR <90 mL/min/1.73m2 using the 2021 CKD-EPI formula
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Women: Hemoglobin <10.5 g/dL; Men: Hemoglobin <11.0 g/dL
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Serum ferritin ≥100 μg/L at Screening
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Serum hepcidin > the normal control median by sex, as determined by the central lab
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Transferrin saturation ≤25%
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Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening
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Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2× upper limit of normal (ULN) at Screening.
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Total and direct bilirubin <ULN at Screening.
Exclusion Criteria:
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Concurrent or planned treatment, or treatment within 30 days prior to screening, with one of the following anemia treatments: erythropoietin stimulating agent, IV iron, or blood transfusion.
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Positive direct antiglobulin test with reactive eluate at Screening or active hemolytic anemia.
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History of hereditary hemochromatosis.
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History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia.
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History of splenectomy.
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Prior hematopoietic cell or solid organ transplant
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Medical history of anemia from Vitamin B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening
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Blood transfusion within 3 months of screening
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Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to Screening
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If female, pregnant or breastfeeding.
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Any major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.
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History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system).
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Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening
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A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug
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History of anti-drug antibody formation
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History of inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or have a history of left ventricular ejection fraction <35%
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Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment)
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Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C.
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Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin therapy within 3 months of screening
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Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.
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Any condition or concomitant medication that would confound the ability to interpret data from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Accel Research | DeLand | Florida | United States | 32720 |
| 2 | Total Research Group | Miami | Florida | United States | 33126 |
| 3 | Florida Pulmonary Research Institute | Winter Park | Florida | United States | 32789 |
| 4 | Aventiv Research Inc | Columbus | Ohio | United States | 43213 |
| 5 | Endeavor Clinical Trials | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Disc Medicine, Inc
Investigators
- Study Director: Will Savage, MD PhD, Disc Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DISC-0974-103