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

NCT04925661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-15

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • Nicoya Therapeutics (Shanghai) Co., Ltd.

    collaborator UNKNOWN

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2023-08-29
Completion
2023-08-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925661 on ClinicalTrials.gov