Clinical Trials in Australia / NCT07649265
Recruiting
Phase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
NCT07649265 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Rheumatoid ArthritisSystemic Lupus ErythematosusSystemic SclerosisSjögren's Disease
Investigational drug(s) / intervention(s)
HBM7020
HBM7020: Liquid formulation, administered through intravenous infusion
Study summary
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).
Eligibility
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.
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through 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 — Up to Week 24
- Number of Participants With Dose limiting AE Evaluation During Dose Escalation — Up to Day 15
- Number of Participants With Clinically Significant Changes in Vital Signs — Up to Week 24
- Number of Participants With Clinically Significant Changes in Physical Examination Findings — Up to Week 24
- Change From Baseline in Serum Interleukin-6 (IL-6) — Up to Week 20
- Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α) — Up to Week 20
- Change From Baseline in Serum Interferon-Gamma (IFN-γ) — Up to Week 20
- Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP) — Up to Week 20
- Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR) — Up to Week 20
- Change From Baseline in Serum Ferritin — Up to Week 20
- Change From Baseline in Serum Immunoglobulin G (IgG) — Up to Week 20
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Q-Pharm Pty Ltd | Brisbane | Queensland | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07649265 on ClinicalTrials.gov ↗ ← All trials in Australia