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.

NCT04470063 | Unknown Phase 1

• 1 other identifier: DDO-3055-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 12

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.

Conditions

Anemia Associated Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events to assess safety and tolerability.

  up to 37 days

Study Arms (3)

group A

EXPERIMENTAL

Drug: DDO-3055 tablets; Drug: Placebo

group B

EXPERIMENTAL

Drug: DDO-3055 tablets; Drug: Placebo

group C

EXPERIMENTAL

Drug: DDO-3055 tablets; Drug: Placebo

Interventions

DDO-3055 tablets DRUG

Multi-dose for DDO-3055 tablets

group A; group B; group C

Placebo DRUG

Multi-dose for Placebo

group A; group B; group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (12)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Sun Yat Sen memorial hospital Sun Yat Sen university

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital，Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Cangzhou People's Hospital

Cangzhou, Henbei, 075000, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 443000, China

Location

Zhongda Hospital Southeast Universtiy

Nanjing, Jiangsu, 210009, China

Location

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Shandong Qianfo Mountain hospital

Jinan, Shandong, 250013, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: November 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

CN (12)