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

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07291323

Enrollment

Registered

2025-12-18

Start date

2026-02-16

Completion date

2026-12-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune

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.

Interventions

DRUGJANX011

JANX011 is administered subcutaneously, one time.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects will receive one dose of JANX011 subcutaneously. Dosage per cohort will increase to determine the maximum tolerable dose.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.	Up to 85 days

Countries

Australia

Contacts

CONTACTJanux Therapeutics

ARMV-011-001_ct.gov@januxrx.com858-206-8471

STUDY_DIRECTORJanux Therapeutics, MD

Janux Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026