- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07649265
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
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
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Otsuka Call Center
- Telefonnummer: 844-687-3522
- E-mail: otsukaprofessionalservices@otsuka-us.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Key Inclusion Criteria for Healthy Participants (Part 1)
- Participants who are of non-childbearing potential or are using acceptable contraception.
- 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 Inclusion Criteria for Patient Participants (Part 1)
- BMI and body weight within an acceptable range.
- Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.
Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1)
- Confirmed autoimmune disease with appropriate supporting autoantibody findings.
- Stable background therapy prior to dosing.
Active moderate to severe disease consistent with protocol-defined disease activity criteria for:
- Systemic lupus erythematosus (SLE)
- Systemic sclerosis (SSc)
- Rheumatoid arthritis (RA)
- Sjögren's disease (SjD)
Key Inclusion Criteria for Rescreening Participants (Part 2)
- Meets Part 1 disease-agnostic inclusion criteria.
- Stable background autoimmune therapy prior to dosing.
- Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.
Key Exclusion Criteria for Parts 1 and 2
- Pregnant or breastfeeding participants.
- Recent vaccination within protocol-defined timelines.
- Clinically significant medical history or abnormal physical examination findings.
- Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
- Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
- Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part 1
Participants will receive HBM7020 in sequential dose-escalation cohorts in Part 1.
|
Liquid formulation, administered through intravenous infusion
|
|
Eksperimentel: Part 2
Participants may receive optional retreatment of HBM7020 in Part 2 if eligible.
|
Liquid formulation, administered through intravenous infusion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Tidsramme: Up to Week 48
|
Up to Week 48
|
|
Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection
Tidsramme: Up to Week 24
|
Up to Week 24
|
|
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Tidsramme: Up to Day 15
|
Up to Day 15
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Tidsramme: Up to Week 24
|
Up to Week 24
|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Tidsramme: Up to Week 24
|
Up to Week 24
|
|
Change From Baseline in Serum Interleukin-6 (IL-6)
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α)
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum Interferon-Gamma (IFN-γ)
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum Ferritin
Tidsramme: Up to Week 20
|
Up to Week 20
|
|
Change From Baseline in Serum Immunoglobulin G (IgG)
Tidsramme: Up to Week 20
|
Up to Week 20
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020
Tidsramme: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020
Tidsramme: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
|
Maximum Observed Plasma Concentration (Cmax) of HBM7020
Tidsramme: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
|
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020
Tidsramme: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
|
|
Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020
Tidsramme: Up to Week 24
|
Up to Week 24
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Mundsygdomme
- Stomatognatiske sygdomme
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Sygdomme i immunsystemet
- Øjensygdomme
- Hudsygdomme
- Xerostomi
- Spytkirtelsygdomme
- Syndromer med tørre øjne
- Sygdomme i tåreapparatet
- Hud- og bindevævssygdomme
- Lupus erythematosus, systemisk
- Sjøgrens syndrom
- Autoimmune sygdomme
- Sklerodermi, systemisk
- Gigt, reumatoid
Andre undersøgelses-id-numre
- 365-201-00001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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