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Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies

NCT06854276 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-03

No results posted yet for this study

Summary

This study employs a multicenter, randomized, open-label, positive drug-controlled, multiple ascending dose clinical trial design to comprehensively evaluate the safety, tolerability, immunogenicity, and pharmacokinetic characteristics of SSS06 injection in patients with chemotherapy-induced anemia from non-myeloid malignancies, while also exploring its potential efficacy.

Conditions

  • Chemotherapy-induced Anemia
  • Non-myeloid Malignancies

Interventions

DRUG

SSS06

SSS06 is a highly glycosylated, long-acting recombinant protein product produced through recombinant gene technology by introducing site-specific mutations into the rHuEPO gene.

DRUG

rhEPO

a recombinant human erythropoietin injection.

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-12-01
Completion
2027-12-01

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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 NCT06854276 on ClinicalTrials.gov