This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Inclusion Criteria:
SLE: subjects:
Exclusion Criteria:
iris.li@antengene.com021-32501095
This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II). Part I (Dose Escalation) consists of 2 dosing stages: Single Ascending Dose (SAD) and Step-Up Dose (SUD). A total of 9 dose levels is preset: 0.01 μg/kg, 0.2 μg/kg, 3 μg/kg, 10 μg/kg, 30 μg/kg, 100 μg/kg, 300 μg/kg, 900 μg/kg, and 1500 μg/kg. In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated in 2 selected indications out of SLE, SSc and SjD.
Bengbu, Anhui, China
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Shanghai, Shanghai Municipality, China
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