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 |
|---|---|---|---|
| Candid Clinical Site | Melbourne | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 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.
Inclusion Criteria (SAD):
1. 18 to 65 years old
2. Body mass index 18-30 kg/m2 and weight 55-100 kg
3. Individuals in good health
4. Agree to abstain from consumption of alcohol 48 hours prior to study visits
5. Agree to the use of highly effective contraception as defined in the protocol
Inclusion Criteria (MAD and Part 2 Expansion):
Patients with RA:
1. 18 to 75 years old
2. Diagnosis of adult-onset RA
3. Class I-III RA
4. Moderately to severely active RA
Patients with SjD:
1. 18 to 75 years old
2. Diagnosis of primary SjD
Exclusion Criteria (SAD):
1. Inadequate clinical laboratory parameters at Screening
2. Active infection
3. Receipt of or inability to discontinue any excluded therapies
4. Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
5. History of alcohol or drug abuse within last 12 months
6. Positive alcohol breathalyzer or drug screen prior to dosing
7. Inability to comply with protocol-mandated requirements
8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug
9. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
10. Blood donation or significant blood loss within 30 days
11. Individuals considered to be part of a vulnerable population (eg, incarceration)
12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
Exclusion Criteria for patients with RA or SjD:
1. Inadequate clinical laboratory parameters at Screening
2. Active infection
3. Receipt of or inability to discontinue any excluded therapies
4. History of progressive multifocal leukoencephalopathy
5. Central nervous system disease
6. Presence of 1 or more significant concurrent medical conditions
7. Have a diagnosis or history of malignant disease within 5 years
8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug
9. Women who are pregnant or breastfeeding
10. Patients who do not agree to the use of highly effective contraception as defined by the protocol
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: 22 July 2026.
- This page last checked by Voxsanity: 11 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.