Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

Keymed Biosciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Primary Immune Thrombocytopenia

Treatments: Other: placebo; Biological: CM313 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06594146

CM313-111101

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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62 participants in 3 patient groups

Group 1

Experimental group

Description:

CM313 injection and placebo

Treatment:

Biological: CM313 injection

Other: placebo

Group 2

Experimental group

Description:

CM313 injection and placebo

Treatment:

Biological: CM313 injection

Other: placebo

Group 3

Experimental group

Description:

CM313 injection and placebo

Treatment:

Biological: CM313 injection

Other: placebo