A Phase 1/2 Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Immune Thrombocytopenia (ITP)
This is a multicenter, open-label Phase1/2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.
• 1\. Willing and able to provide written informed consent for this trial.
• 2\. Male or female, age ≥ 18 years on the day of signing the informed consent form.
• 3\. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.
• 4\. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.
• 5\. At screening, Platelet Count revealed \< 30 \* 10\^9/L twice (with an interval of at least 24 hours between the two tests).
• 6\. Subjects must have adequate organ function.
• 7\. The World Health Organization (WHO) bleeding scale is 0-1.
• 8\. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.