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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Adverse event
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group 1
CM313 injection and placebo
Intervention: CM313 injection (Biological)
Group 1
CM313 injection and placebo
Intervention: placebo (Other)
Group 2
CM313 injection and placebo
Intervention: CM313 injection (Biological)
Group 2
CM313 injection and placebo
Intervention: placebo (Other)
Group 3
CM313 injection and placebo
Intervention: CM313 injection (Biological)
Group 3
CM313 injection and placebo
Intervention: placebo (Other)
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)
Secondary Outcomes
No secondary outcomes reported