Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.

Hengrui Medicine

Status and phase: Invitation-only; Phase 1

Conditions: Anemia Associated Chronic Kidney Disease

Treatments: Drug: DDO-3055 tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04470063

DDO-3055-104

Details and patient eligibility

About

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CKD anemia aged 18-70 years who were not on dialysis and were not expected to undergo dialysis during the study period, regardless of gender;
• Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI<28kg/m2;
• Signed informed consent.

Exclusion criteria

• Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
• Patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein thrombosis or pulmonary embolism) or a history of seizures within 6 months before screening;
• Patients with uncontroll ed hypertension;
• New York Heart Association grade III or IV congestive heart failure at the time of screening;
• ALT,AST or total bilirubin exceeds 1.5 times the upper limit of normal value (ULN) during the screening period;
• Suffer from anemia other than CKD.
• Patients with a history of chronic liver disease;
• Patients with active bleeding or known coagulopathy;
• Patients who have any previous organ transplant or plan to perform organ transplant;
• Intravenous iron supplementation within 1 month before screening;
• Used erythropoiesis stimulator (ESAs), hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), androgen, blood transfusion therapy within 3 months before screening;
• Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, and human immunodeficiency virus (HIV) antibody were positive;
• Patients with blood loss ≥400mL within 3 months before screening;
• Subjects who have taken other clinical trial drugs or are expected to have a legacy effect of the trial treatment;
• Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;or male and female subjects who did not agree to use physical contraception during the trial;
• Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening;
• According to the study physician's judgment, there may be any other anemia factors that may exist, any possibility to increase the risk of the study, affect the subject's compliance with the protocol, or affect the physical or psychological disease or condition of the subject to complete the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

group A

Experimental group

Treatment:

Drug: Placebo

Drug: DDO-3055 tablets

group B

Experimental group

Treatment:

Drug: Placebo

Drug: DDO-3055 tablets

group C

Experimental group

Treatment:

Drug: Placebo

Drug: DDO-3055 tablets