Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

Phase 2Active Not RecruitingNCT06594146

Keymed Biosciences Co.Ltd62 enrolled

Overview

This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Immune Thrombocytopenia

Interventions

CM313 injectionBIOLOGICAL

CM313

placeboOTHER

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old ≤ 75 years old, male or female. * Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form. Exclusion Criteria: * Previously received allogeneic stem cell transplantation or organ transplantation. * Laboratory abnormalities with clinical significance at screening visit. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period. * With any other situations that are not suitable for participation in this study by the investigator.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

Outcomes

Primary Outcomes

Adverse event

Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame: Up to Week 16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.