Testing JANX011 for safety and tolerability in healthy adults.
Official title: A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of JANX011 With Optional Step-Up Dosing in Healthy Adult Volunteers
Run by Janux Therapeutics · NCT07291323 · Data updated 2026-11-12
This trial tests JANX011 given by injection in healthy adults to see if it is safe, well tolerated, and to measure how the drug behaves and affects the immune system.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Janux Therapeutics Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07291323 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18 to 65 years, weighing 50–120 kg with BMI 18–32 kg/m2, who have no active infections or prohibitive medical history and who can provide informed consent are ideal candidates for this study.
✕Probably not a fit
People with active autoimmune disease, those with positive tests for hepatitis B/C, HIV, or tuberculosis, or those with recent major surgery are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human, early-phase 1 interventional trial enrolls healthy adult volunteers to receive JANX011 subcutaneously and potentially intravenously to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics. Participants will undergo screening with physical exams and laboratory tests, receive one or more doses under close clinical monitoring, and have serial blood sampling for drug levels and immune markers. Adverse events and clinical safety signals will be recorded to inform dose selection and design of subsequent patient studies for autoimmune conditions.
Why it matters
Potential benefit: If successful, JANX011 could become a new immune-targeting treatment option for autoimmune diseases with an acceptable safety profile.
How similar studies have gone: This is a first-in-human study for JANX011; while other biologic immune-modulating agents have shown benefit in autoimmune diseases, JANX011's effects in humans are untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy men and women, in the opinion of the PI or designee and as determined by physical examination, laboratory screening tests, and medical history. * Aged 18 to 65 years, with a body weight between 50 to 120 kg and a body mass index (BMI) between 18 to 32 kg/m2 (all inclusive) at Screening. * Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures. Exclusion Criteria: * Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study. * Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus 1 (HIV-1) or HIV-2 antibodies. * Positive test for tuberculosis (TB) or history of TB (including prior positive interferon gold test result). * Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to dosing on Day 1.
Where it's running
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Cmax
Adelaide, South Australia, Australia Recruiting
Study contacts
- Study coordinator: Janux Therapeutics
- Email: ARMV-011-001_ct.gov@januxrx.com
- Phone: 858-206-8471
Similar studies
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JANX014 for metastatic castration-resistant prostate cancer
This trial will test whether JANX014 is safe, how your body handles it, and whether it shows signs of benefit in adults with metastatic castration-resistant prostate cancer who have already had anti-androgen therapy and typically a taxane.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.