NCT06594146
Active, not recruiting
Phase 2
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Initial Efficacy of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia
Keymed Biosciences Co.Ltd1 site in 1 country62 target enrollmentNovember 11, 2024
Overview
- Phase
- Phase 2
- Intervention
- CM313 injection
- Conditions
- Primary Immune Thrombocytopenia
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Adverse event
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1
CM313 injection and placebo
Intervention: CM313 injection
Group 1
CM313 injection and placebo
Intervention: placebo
Group 2
CM313 injection and placebo
Intervention: CM313 injection
Group 2
CM313 injection and placebo
Intervention: placebo
Group 3
CM313 injection and placebo
Intervention: CM313 injection
Group 3
CM313 injection and placebo
Intervention: placebo
Outcomes
Primary Outcomes
Adverse event
Time Frame: Up to Week 16
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Study Sites (1)
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