Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Disc Medicine, Inc

Criteria

Inclusion criteria:

1. Aged from 18-75 years of age, inclusive, at the time of signing informed consent.

2. Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR <90 mL/min/1.73m2 using the 2021 CKD-EPI formula

3. Women: Hemoglobin <10.5 g/dL; Men: Hemoglobin <11.0 g/dL

4. Serum ferritin ≥100 μg/L at Screening

5. Serum hepcidin > the normal control median by sex, as determined by the central lab

6. Transferrin saturation ≤25%

7. Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening

8. Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2× upper limit of normal (ULN) at Screening.

9. Total and direct bilirubinExclusion Criteria:

1. 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.

2. Positive direct antiglobulin test with reactive eluate at Screening or active hemolytic anemia.

3. History of hereditary hemochromatosis.

4. History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia.

5. History of splenectomy.

6. Prior hematopoietic cell or solid organ transplant

7. Medical history of anemia from Vitamin B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening

8. Blood transfusion within 3 months of screening

9. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to Screening

10. If female, pregnant or breastfeeding.

11. Any major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.

12. 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).

13. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening

14. A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug

15. History of anti-drug antibody formation

16. 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%

17. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment)

18. Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C.

19. Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin therapy within 3 months of screening

20. Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.

21. Any condition or concomitant medication that would confound the ability to interpret data from the study.