NCT07291323

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: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Janux Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	JANX011	JANX011 is administered subcutaneously, one time.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Australia