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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001

NCT ID: NCT06331728

Last Updated: 2025-11-14

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-11-06

Brief Summary

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The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.

Detailed Description

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Conditions

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Peanut Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment.

Study Groups

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IGNX001

Participants will receive IGNX001 given as a single subcutaneous dose on Day 1.

Group Type EXPERIMENTAL

IGNX001

Intervention Type DRUG

IGNX001 given as a single subcutaneous dose on Day 1.

Placebo

Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to IGNX001 given as a single subcutaneous dose on Day 1.

Interventions

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IGNX001

IGNX001 given as a single subcutaneous dose on Day 1.

Intervention Type DRUG

Placebo

Placebo to IGNX001 given as a single subcutaneous dose on Day 1.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IgGenix Australia Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Vincent's Sydney

Darlinghurst, New South Wales, Australia

Site Status

Monash Health, Sleep, Allergy, and Immunology

Clayton, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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IGNX-T1

Identifier Type: -

Identifier Source: org_study_id