A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants who give consent to this study participation and sign informed consent form.
• Participants at least 18 years of age inclusive at screening visit.
• Must be able to adhere to the study visit schedule and other protocol .requirements.
• Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.
• Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
NOT_YET_RECRUITING
Bengbu
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Nanfang Hospital of Southern Medical Universit
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of University of Science and Technology of China
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Linyi People's Hospital
NOT_YET_RECRUITING
Linyi
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
NOT_YET_RECRUITING
Nanjing
Huashan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Nuclear Industry General Hospital
NOT_YET_RECRUITING
Suzhou
The First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Iris Li
iris.li@antengene.com
021-32501095
Time Frame
Start Date:2026-09-26
Estimated Completion Date:2029-06-01
Participants
Target number of participants:149
Treatments
Experimental: ATG-201
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) A total of 9 dose levels is preset In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated