NCT04925661

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Kidney Diseases
• Renal Anemia

Interventions

Type	Name	Description
DRUG	HEC53856	Either dose of HEC53856 will be administered after fasting .
DRUG	Roxadustat	Roxadustat will be administered after fasting .
DRUG	Placebo	Either dose of placebo will be administered after fasting .

Timeline

• Start date: 2021-11-04
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2021-06-14
• Last updated: 2025-05-15

Locations

8 sites across 1 country: China