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

NCT07291323 | Recruiting Early Phase 1 DMC

• 1 other identifier: ARMV-011-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune

Outcome Measures

Primary Outcomes (1)

• Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.

  Up to 85 days

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Dosage per cohort will increase to determine the maximum tolerable dose.

Drug: JANX011

Interventions

JANX011 DRUG

JANX011 is administered subcutaneously, one time.

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janux Therapeutics: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

RECRUITING

Study Officials

• Janux Therapeutics, MD

  Janux Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Janux Therapeutics

CONTACT

858-206-8471; ARMV-011-001_ct.gov@januxrx.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)