A Study of ATG-201 in Adult Participants With Autoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Biologics Limited
About this trial
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).
Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.
Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.
Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.
Trial design
Treatments tested in this trial
- ATG-201
Treatment groups
149 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov