HBM7020
DrugLiquid formulation, administered through intravenous infusion
NCT Number: NCT07649265
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. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria for Healthy Participants (Part 1)
Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)
Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1)
Key Inclusion Criteria for Rescreening Participants (Part 2)
Key Exclusion Criteria for Parts 1 and 2
Liquid formulation, administered through intravenous infusion
Time frame: Up to Week 48
Time frame: Up to Week 24
Time frame: Up to Day 15
Time frame: Up to Week 24
Time frame: Up to Week 24
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Up to Week 20
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time frame: Up to Week 24
Contact information is provided by the study sponsor or research team.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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