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.

Study Overview
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Brief Summary
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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.

Official Title
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A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.

Conditions
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Anemia Associated Chronic Kidney Disease

Intervention / Treatment
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* Drug: DDO-3055 tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br> | Drug: DDO-3055 tablets<br>* Multi-dose for DDO-3055 tablets<br>Drug: Placebo<br>* Multi-dose for Placebo<br>|
| Experimental: group B<br> | Drug: DDO-3055 tablets<br>* Multi-dose for DDO-3055 tablets<br>Drug: Placebo<br>* Multi-dose for Placebo<br>|
| Experimental: group C<br> | Drug: DDO-3055 tablets<br>* Multi-dose for DDO-3055 tablets<br>Drug: Placebo<br>* Multi-dose for Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events to assess safety and tolerability. |  | up to 37 days |