NCT07014631

Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD

A Phase II Dose-Finding Study to Evaluate the Efficacy and Safety of Oral SSS17 Capsules for Anemia in Non-Dialysis Chronic Kidney Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study primarily evaluates the efficacy and safety of oral SSS17 capsules in treating anemia in patients with non-dialysis chronic kidney disease, as well as the pharmacokinetic and pharmacodynamic (PK/PD) characteristics of different doses of SSS17 capsules for anemia treatment in this patient population.

Detailed description

This dose-finding study comprises three distinct dosing cohorts:cohort 1-3 once weekly . Each cohort will enroll patients at a 4:1 ratio (SSS17:placebo), allocating 32 subjects to active treatment and 8 to placebo control per group. The total planned enrollment is 120 non-dialysis chronic kidney disease (CKD) patients with anemia. The trial will initiate with Cohort 1. Dosing regimens for subsequent cohorts may be modified based on predefined pharmacokinetic (PK), pharmacodynamic (PD), and safety evaluations from preceding cohorts, including potential adjustments to dose levels and/or administration frequency.

Conditions

• Anemia in Pre-Dialysis Patients

Interventions

Type	Name	Description
DRUG	SSS17	The SSS17 treatment arm comprises three dose levels: the first two dose levels will have an 8-week treatment duration, while the third dose level will extend to 24 weeks. At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.
DRUG	Placebo	At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.Placebo recipients will undergo weekly dosing identical to the active treatment group within their assigned dose cohort.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-12
• Completion: 2025-04-08
• First posted: 2025-06-11
• Last updated: 2025-06-18

Locations

1 site across 1 country: China