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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

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

63

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Key Inclusion Criteria for Healthy Participants (Part 1)

  1. Participants who are of non-childbearing potential or are using acceptable contraception.
  2. Body mass index (BMI) and body weight within an acceptable range.
  3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.

Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)

  1. BMI and body weight within an acceptable range.
  2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.

Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1)

  1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.
  2. Stable background therapy prior to dosing.
  3. 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)

  1. Meets Part 1 disease-agnostic inclusion criteria.
  2. Stable background autoimmune therapy prior to dosing.
  3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.

Key Exclusion Criteria for Parts 1 and 2

  1. Pregnant or breastfeeding participants.
  2. Recent vaccination within protocol-defined timelines.
  3. Clinically significant medical history or abnormal physical examination findings.
  4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
  5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
  6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

20. november 2028

Studieafslutning (Anslået)

20. november 2028

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD-delingstidsramme

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD-delingsadgangskriterier

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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