Clinical trial NCT06331728: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peanut Allergy
Lead sponsor: IgGenix Australia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 ≥ 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.

Primary outcomes:
measure: Incidence and Severity of Treatment Emergent Adverse Events
timeFrame: From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
measure: Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
timeFrame: From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
measure: Number of Participants with Clinically significant Changes from Baseline - Hematology
timeFrame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
measure: Number of Participants with Clinically Significant Changes from Baseline - Chemistry
timeFrame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
measure: Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves
timeFrame: Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks).
measure: Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations
timeFrame: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Secondary outcomes:
measure: Concentration of IGNX001 in the Plasma
timeFrame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
measure: Measurement of Area under the Plasma/Serum Concentration Curve (AUC)
timeFrame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
measure: Peak Serum Concentration (Cmax)
timeFrame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
measure: Time to Peak Serum Concentration (Tmax)
timeFrame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).
measure: Elimination Half-life (t1/2)
timeFrame: Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).
measure: Changes Over Time to Anti-drug Antibodies
timeFrame: Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St Vincent's Sydney
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health, Sleep, Allergy, and Immunology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
Study officials:
References: