This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).
Signed informed consent form
Age ≥ 18 and ≤ 85 at the time of signing informed consent form with Karnofsky score ≥ 60 % at screening
Ability to comply with the study protocol
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods
History of anaphylaxis or hypersensitivity to a biologic agent
Active infection requiring systemic antiviral, antibiotics or antifungal
Planned surgery during the study
Pregnant or breastfeeding, or intending to become pregnant
Single group
RAY121
DrugInjection
Adverse events (AEs)
Incidence, severity, and causal relationship of AEs
RAY121 concentration
Serum RAY121 concentration
AUCτ
Area under the concentration-time curve over a dosing interval (AUCτ)
Cmax
Maximum observed serum concentration (Cmax)
Cmin
Minimum observed serum concentration (Cmin)
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