Testing JANX011 for safety and tolerability in healthy adults.
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Janux Therapeutics Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT07291323 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Adelaide, South Australia
- Cmax — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Janux Therapeutics
- Email: ARMV-011-001_ct.gov@januxrx.com
- Phone: 858-206-8471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.