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Clinical Trials in Australia / NCT07291323
Recruiting Phase EARLY_PHASE1

Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.

NCT07291323 · tracked via the Priya Life Science Australia tracker
Phase
Phase EARLY_PHASE1
Started
2026-02-16
Last updated
2026-04-23

Condition(s) studied

Autoimmune

Investigational drug(s) / intervention(s)

JANX011

JANX011: JANX011 is administered subcutaneously, one time.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CMAX Adelaide South Australia Recruiting

More Janux Therapeutics trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07291323 on ClinicalTrials.gov ↗ ← All trials in Australia