NCT07291323 Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.
| NCT ID | NCT07291323 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Janux Therapeutics |
| Condition | Autoimmune |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-02-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to gain insight into its therapeutic utility in patients with autoimmune diseases.
Eligibility 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.
Contact & Investigator
Janux Therapeutics, MD
STUDY DIRECTOR
Janux Therapeutics
Frequently Asked Questions
Who can join the NCT07291323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Autoimmune. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07291323 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07291323 currently recruiting?
Yes, NCT07291323 is actively recruiting participants. Contact the research team at ARMV-011-001_ct.gov@januxrx.com for enrollment information.
Where is the NCT07291323 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT07291323 clinical trial?
NCT07291323 is sponsored by Janux Therapeutics. The principal investigator is Janux Therapeutics, MD at Janux Therapeutics. The trial plans to enroll 60 participants.