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

Janux Therapeutics2 sites in 1 country60 target enrollmentFebruary 16, 2026

InterventionsJANX011

DrugsJANX011

Overview

Phase: Early Phase 1
Intervention: JANX011
Conditions: Not specified
Sponsor: Janux Therapeutics
Enrollment: 60
Locations: 2
Primary Endpoint: Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
Status: Recruiting
Last Updated: 9 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 16, 2026

End Date

December 1, 2026

Last Updated

9 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Janux Therapeutics

Responsible Party

Sponsor

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.