NCT06331728

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: IgGenix Australia Pty Ltd · Industry
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

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

• Peanut Allergy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2024-03-26
• Last updated: 2025-11-14

Locations

4 sites across 1 country: Australia