RecruitingPhase 1interventionalRules rewrite

Phase 1: testing ATG-201 for Systemic Lupus Erythematosus

Q: Is NCT07732309 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07732309?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07732309?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

Official registry: https://clinicaltrials.gov/study/NCT07732309 · Antengene Biologics Limited · enrollment listed as 149

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ATG-201. The registry lists allocation as na. This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

They plan to enroll about 149 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ATG-201

Primary outcome (registry wording): Safety and TolerabilitySafety and Tolerability

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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
History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant
Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study
Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\>60 mg/day) within 2 months prior to screening

Public study contact (from the registry)

Iris Li

021-32501095

iris.li@antengene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

22 listed

The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (not_yet_recruiting)
The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (not_yet_recruiting)
Peking University People's Hospital — Beijing, Beijing Municipality, China (recruiting)
The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (not_yet_recruiting)
Nanfang Hospital of Southern Medical Universit — Guangzhou, Guangdong, China (not_yet_recruiting)
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit — Guangzhou, Guangdong, China (not_yet_recruiting)
The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (not_yet_recruiting)
The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (not_yet_recruiting)
The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (not_yet_recruiting)
The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (not_yet_recruiting)
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (not_yet_recruiting)
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07732309 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07732309?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07732309?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary