Phase 1 study
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Q-Pharm Pty Ltd | Brisbane | QLD | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.