Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing HBM7020 for Rheumatoid Arthritis

This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement.

Official registry: https://clinicaltrials.gov/study/NCT07649265 · Otsuka Pharmaceutical Development & Commercialization, Inc. · enrollment listed as 63

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 HBM7020. The registry lists allocation as randomized. This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.

They plan to enroll about 63 people at Brisbane. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease

Interventions: HBM7020

Primary outcome (registry wording): Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Key for Healthy Participants (Part 1)
  • Participants who are of non-childbearing potential or are using acceptable contraception
  • Body mass index (body-mass index (BMI)) and body weight within an acceptable range
  • Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments
  • Key Disease-Agnostic who can join for Patient Participants (Part 2)
  • body-mass index (BMI) and body weight within an acceptable range
  • Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters

Public study contact (from the registry)

Otsuka Call Center

844-687-3522

otsukaprofessionalservices@otsuka-us.com

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

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07649265 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 NCT07649265?

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 NCT07649265?

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