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.
NCT ID: NCT04470063
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2020-11-17
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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group A
DDO-3055 tablets
Multi-dose for DDO-3055 tablets
Placebo
Multi-dose for Placebo
group B
DDO-3055 tablets
Multi-dose for DDO-3055 tablets
Placebo
Multi-dose for Placebo
group C
DDO-3055 tablets
Multi-dose for DDO-3055 tablets
Placebo
Multi-dose for Placebo
Interventions
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DDO-3055 tablets
Multi-dose for DDO-3055 tablets
Placebo
Multi-dose for Placebo
Eligibility Criteria
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Inclusion Criteria
* Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI\<28kg/m2;
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Sun Yat Sen memorial hospital Sun Yat Sen university
Guangzhou, Guangdong, China
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Henbei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shandong Qianfo Mountain hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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DDO-3055-104
Identifier Type: -
Identifier Source: org_study_id