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

NCT ID: NCT07291323

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autoimmune

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

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

Group Type EXPERIMENTAL

JANX011

Intervention Type DRUG

JANX011 is administered subcutaneously, one time.

Interventions

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JANX011

JANX011 is administered subcutaneously, one time.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janux Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zach McIver, D.O., PhD

Role: STUDY_CHAIR

Janux Therapeutics

Locations

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CMAX

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Central Contacts

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Janux Therapeutics

Role: CONTACT

Phone: 858-206-8471

Email: [email protected]

Other Identifiers

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ARMV-011-001

Identifier Type: -

Identifier Source: org_study_id