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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Adverse event — Up to Week 16 Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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