Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001
NCT06331728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-11-14
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.
Conditions
Interventions
- DRUG
-
IGNX001
IGNX001 given as a single subcutaneous dose on Day 1.
- DRUG
-
Placebo to IGNX001 given as a single subcutaneous dose on Day 1.
Sponsors & Collaborators
-
IgGenix Australia Pty Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2025-11-06
- Completion
- 2025-11-06
Countries
- Australia
Study Locations
More Related Trials
-
Peanut Oral Immunotherapy in Children
NCT01867671 ·Status: COMPLETED ·Phase: PHASE2
-
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
NCT00932282 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
NCT07287033 ·Status: RECRUITING ·Phase: PHASE1
-
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
NCT07117669 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
NCT03881696 ·Status: COMPLETED ·Phase: PHASE3
-
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
NCT03682770 ·Status: COMPLETED ·Phase: PHASE2
-
The Grown Up Peanut Immunotherapy Study
NCT03648320 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
NCT04984876 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
NCT00382148 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial
NCT00580606 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
HAL-MPE1 Safety and Tolerability Study
NCT02991885 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
NCT07015996 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
NCT05432388 ·Status: COMPLETED ·Phase: PHASE2
-
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
NCT03292484 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
NCT01084174 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
NCT05138757 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
NCT03070561 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
NCT04603300 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
NCT06342713 ·Status: RECRUITING ·Phase: PHASE1
-
STEP-IT-UP - Peanut Allergy Study for Infants
NCT04761835 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
NCT04415073 ·Status: TERMINATED ·Phase: PHASE2
-
PALISADE Follow-on Study (ARC004)
NCT02993107 ·Status: COMPLETED ·Phase: PHASE3
-
Omalizumab in the Treatment of Peanut Allergy
NCT00949078 ·Status: COMPLETED ·Phase: PHASE2
-
Epicutaneous Immunotherapy in Peanut Allergy in Children
NCT01197053 ·Status: COMPLETED ·Phase: PHASE2
-
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
NCT01090622 ·Status: COMPLETED ·Phase: PHASE1/PHASE2