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

NCT04925661 | Completed Phase 1

• 1 other identifier: HEC53856-RAD-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Chronic Kidney Diseases; Renal Anemia

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  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 Outcomes (15)

• AUC0-t

  Day 1(Dosing) until Day 55 after single and multiple drug dosing.

• Cmax

  Day 1(Dosing) until Day 55 after single and multiple drug dosing.

• Tmax

  Day 1(Dosing) until Day 55 after single and multiple drug dosing.

• T½

  Day 1(Dosing) until Day 55 after single and multiple drug dosing.

• Vz/F

  Day 1(Dosing) until Day 55 after single and multiple drug dosing.

Study Arms (3)

HEC53856

EXPERIMENTAL

Drug: HEC53856 TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg

Drug: HEC53856

Roxadustat

ACTIVE COMPARATOR

Drug: roxadustat TIW dosing There will be only one cohort: 70mg

Drug: Roxadustat

Placebo

PLACEBO COMPARATOR

Drug: placebo TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg

Drug: Placebo

Interventions

HEC53856 DRUG

Either dose of HEC53856 will be administered after fasting .

HEC53856

Roxadustat DRUG

Roxadustat will be administered after fasting .

Roxadustat

Placebo DRUG

Either dose of placebo will be administered after fasting .

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients who agree to participate in this clinical trial and sign an informed consent form;
• Age 18\~65 years old; Weight 40\~90Kg, including critical value;
• 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;
• 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.

You may not qualify if:

• 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;
• 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.);
• Those who have received blood transfusion within 3 months before the first administration;
• Folic acid \<6.8nmol/L (3ng/ml) and (or) VitB12\<74pmol/L (100ng/ml) during the screening period;
• 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;
• Serum albumin \<3 g/dL;
• 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;
• Suffering from uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH \> 500pg/ml;
• A history of acute or chronic pancreatitis, or acute or chronic pancreatitis at the time of screening, or blood amylase \> or = 3×ULN;
• 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;
• 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;
• 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.;
• AIDS antibody, Treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody positive for any of them;
• People with a history of severe allergic disease or drug allergy, or those who are allergic to experimental drugs or their excipients;
• Patients with clinically severe infections who are receiving systemic antibiotic treatment;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead
• Nicoya Therapeutics (Shanghai) Co., Ltd.: collaborator

Study Sites (8)

The sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Zhejiang Provincal People's Hospital

Hangzhou, China

Location

The People's Hospital of Guangxi Zhuang Autonmous Region

Nanning, China

Location

Huashan Hospital

Shanghai, China

Location

Ruijin Hospital

Shanghai, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The positive drug is Masking and the placebo-controlled is open.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 14, 2021
• Study Start: November 4, 2021
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: May 15, 2025

Record last verified: 2023-04

Locations

CN (8)