Primary Immune Thrombocytopenia
Conditions
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 patients with primary immune thrombocytopenia.
Interventions
BIOLOGICALCM313 injection
CM313
OTHERplacebo
placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Up to Week 16 | Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) |
Countries
China
Outcome results
None listed