HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia

June 21, 2021 updated by: Sunshine Lake Pharma Co., Ltd.

Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.

Study Overview

Status

Not yet recruiting

Detailed Description

This is a MultiCenter, Randomized, Blinded, Active Drug and Placebo-controlled, Dose-escalated Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia. Each part participants will be randomly administrated for HEC53856 or placebo or roxadustat.

The study consisted of three study periods as follows:

Screening period: up to 2 weeks; Treatment period: 8 weeks; Post-Treatment Follow-Up period: 4 weeks.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Guangzhou, China
        • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Hangzhou, China
        • Zhejiang Provincal People's Hospital
      • Nanning, China
        • The People's Hospital of Guangxi Zhuang Autonmous Region
      • Shanghai, China
        • Ruijin Hospital
      • Shanghai, China
        • Huashan Hospital
      • Xi'an, China
        • First Affiliated Hospital of Xi'an JiaoTong University
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Ürümqi, China
        • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who agree to participate in this clinical trial and sign an informed consent form;
  2. Age 18~65 years old; Weight 40~90Kg, including critical value;
  3. Glomerular filtration rate (eGFR) calculated by CKD-EPI formula 15mL/min/1.73 m^2 < or = eGFR < 60 mL/min/1.73 m^2 diagnosed chronic kidney disease patients who have not received dialysis;
  4. The hemoglobin values obtained during the last two screening periods at least 6 days apart must be > or = 8.0 g/dL and <10 g/dL.

Exclusion Criteria:

  1. Existence of diseases or conditions other than nephropathy that may cause anemia, including but not limited to 1) blood system diseases, such as thalassemia, aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.; 2) may affect red blood cells The resulting autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, etc.; 3) Bleeding diseases, such as gastrointestinal bleeding, obstetrics and gynecology bleeding diseases, etc.; 4) Elective surgery expected during the study period;
  2. Drugs used to treat anemia within 8 weeks before the first administration, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor prolyl hydroxylase inhibitors (HIF-PHI), androgens And anabolic hormone drugs, intravenous iron, Chinese patent medicine, Chinese herbal medicine, etc. (Can accept patients who have used a fixed dose of oral iron within 4 weeks before screening, and continue to take it during the screening period and the first 4 weeks after starting to take the test drug The fixed dose remains unchanged.);
  3. Those who have received blood transfusion within 3 months before the first administration;
  4. Folic acid <6.8nmol/L (3ng/ml) and (or) VitB12<74pmol/L (100ng/ml) during the screening period;
  5. Clinically significant chronic liver and gallbladder disease, or obvious abnormal liver function: ALT>3×ULN and/or AST>3×ULN, or total bilirubin>1.5×ULN;
  6. Serum albumin <3 g/dL;
  7. The mean systolic blood pressure > or = 160 mmHg and/or the diastolic blood pressure > or = 100 mmHg of the two blood pressure measurements at least one hour apart during the screening period;
  8. Suffering from uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH > 500pg/ml;
  9. A history of acute or chronic pancreatitis, or acute or chronic pancreatitis at the time of screening, or blood amylase > or = 3×ULN;
  10. History of malignant tumors within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ), or current assessment of potential malignant tumors;
  11. Patients with acute coronary syndrome, stroke ( except for lacunar infarction )or thromboembolic diseases (such as deep vein thrombosis or pulmonary embolism) occurred in the 6 months before screening;
  12. New York Society of Cardiology, grade III or IV congestive heart failure, or severe arrhythmia, including but not limited to atrial fibrillation, III degree atrioventricular block, etc.;
  13. AIDS antibody, Treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody positive for any of them;
  14. People with a history of severe allergic disease or drug allergy, or those who are allergic to experimental drugs or their excipients;
  15. Patients with clinically severe infections who are receiving systemic antibiotic treatment;
  16. Those who have started dialysis or plan to start dialysis treatment within 6 months;
  17. Anyone who has participated in or plans to participate in organ transplantation within 6 months;
  18. Patients with hemoglobinosis, polycystic kidney disease, or no kidney;
  19. Women during pregnancy or lactation, or fertile men and women who refuse to take effective contraceptive measures voluntarily from the beginning of screening to 4 weeks after the administration of the last trial drug;
  20. Participated in other clinical trials within 3 months before screening (Definition of participation: accepted trial drug or instrument);
  21. The investigator believes that there are other factors that are not suitable for participating in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEC53856
Drug: HEC53856 TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg
Either dose of HEC53856 will be administered after fasting .
Active Comparator: Roxadustat
Drug: roxadustat TIW dosing There will be only one cohort: 70mg
Roxadustat will be administered after fasting .
Placebo Comparator: Placebo
Drug: placebo TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg
Either dose of placebo will be administered after fasting .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Through study completion, an average of 12 weeks.
To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule
Through study completion, an average of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-t
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Cmax
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Maximum observed plasma concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Tmax
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Time of the maximum observed plasma concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Apparent terminal elimination half-life
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Vz/F
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Apparent volume of distribution
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Changes in mean hemoglobin
Time Frame: week 10
Changes in mean hemoglobin (Hb) relative to baseline during weeks 8 and 10.
week 10
Hemoglobin response
Time Frame: week 10
Percentage of subjects who met the hemoglobin response after dosing
week 10
E-AUC0-t
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Emax
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Maximum observed EPO concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
E-Tmax
Time Frame: Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Time of the maximum observed EPO concentration
Day 1(Dosing) until Day 55 after single and multiple drug dosing.
Serum lipid
Time Frame: Up to Day 55
Changes in Serum lipid relative to baseline at weeks 8.
Up to Day 55
Indicators of iron
Time Frame: Up to Day 55
Changes in the Indicators of iron relative to baseline at weeks 8.
Up to Day 55
High-sensitivity C-reactive protein
Time Frame: Up to Day 55
Changes in the High-sensitivity C-reactive protein relative to baseline at weeks 8.
Up to Day 55
Reticulocytes
Time Frame: Up to Day 85
Changes in the mean Reticulocytes relative to baseline after doses.
Up to Day 85
VEGF
Time Frame: Up to Day 55
Changes in the VEGF relative to baseline after doses.
Up to Day 55

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 29, 2021

Primary Completion (Anticipated)

December 26, 2022

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HEC53856-RAD-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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