Status:
ACTIVE_NOT_RECRUITING
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Primary Immune Thrombocytopenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06594146
Start Date
November 11 2024
End Date
December 30 2025
Last Update
April 23 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China