Clinical trial NCT04470063: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anemia Associated Chronic Kidney Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence and severity of adverse events to assess safety and tolerability.
timeFrame: up to 37 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat Sen memorial hospital Sun Yat Sen university
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital，Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Henbei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast Universtiy
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Shandong Qianfo Mountain hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: