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New shot could tame peanut allergies in one dose

NCT ID NCT06331728

Disease control Sponsor: IgGenix Australia Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a single injection of a new drug called IGNX001 in 32 adults and teens with peanut allergies. The main goal was to check safety and how the body processes the drug. Participants received either the drug or a placebo, and researchers monitored for side effects and allergic reactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IGNX001
What this could lead to
If successful, this could lead to a single-dose treatment that reduces peanut allergy reactions, offering a new option for managing this condition.
What could go wrong
This is an early Phase 1 trial with only 32 participants, focused on safety. It may not show effectiveness, and side effects or lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Sep 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years). * Peanut specific IgE level ≥ 1 kUA/L. * Positive peanut SPT with wheal diameter ≥ 5 mm. Key Exclusion Criteria: * History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening. * Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study. * Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peanut allergy

Contacts and locations

Locations

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Monash Health, Sleep, Allergy, and Immunology

    Clayton, Victoria, 3168, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • St Vincent's Sydney

    Darlinghurst, New South Wales, 2010, Australia

More trials for these conditions

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