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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	15 Years - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

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 ≥ 5 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06331728
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IgGenix Australia Pty Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Arms & Interventions

Arms

Experimental: IGNX001

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

Placebo Comparator: Placebo

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

Interventions

Drug: - IGNX001

IGNX001 given as a single subcutaneous dose on Day 1.

Drug: - Placebo

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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