NCT06038279 is a Phase 1 clinical trial of INI-2004 in Allergic Rhinitis Due to Weed Pollen, sponsored by Inimmune Corporation.

Who is sponsoring NCT06038279?

NCT06038279 is sponsored by Inimmune Corporation.

What drugs are being tested in NCT06038279?

Interventions in NCT06038279: INI-2004, Placebo.

What condition does NCT06038279 study?

NCT06038279 studies Allergic Rhinitis Due to Weed Pollen, Allergic Rhinitis.

Is NCT06038279 still recruiting?

NCT06038279 is currently completed. Last updated 16 January 2026.

Last reviewed 2026-01-16 · How we verify

NCT06038279

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.

Completed Phase 1 Last updated 16 January 2026

What this trial tests

Phase 1 trial testing INI-2004 in Allergic Rhinitis Due to Weed Pollen in 68 participants. Completed in 5 September 2024.

Timeline

4 July 2023

Primary endpoint
5 September 2024

5 September 2024

Quick facts

Lead sponsor	Inimmune Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	68
Start date	4 July 2023
Primary completion	5 September 2024
Estimated completion	5 September 2024
Sites	1 location across Australia

Drugs / interventions tested

INI-2004 — full drug profile →
Placebo

Conditions studied

Allergic Rhinitis Due to Weed Pollen — all drugs for Allergic Rhinitis Due to Weed Pollen →
Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Inimmune Corporation — full company profile →

Who can join

Adults 18 to 64, any sex, with Allergic Rhinitis Due to Weed Pollen or Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Pattern recognition receptors: function, regulation and therapeutic potential.
Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
Intranasal administration of a synthetic TLR4 agonist INI-2004 significantly reduces allergy symptoms following therapeutic administration in a murine model of allergic sensitization.
Jackson KJ, Buhl C, Miller SM, Khalaf JK, et al · · 2024 · cited 2× · PMID 39108263 · DOI 10.3389/fimmu.2024.1421758
Promoting immune defensive responses of epithelial cells in airway disease.
Parnham MJ, Norris V, Kricker JA. · · 2025 · PMID 41246133 · DOI 10.3389/falgy.2025.1697194

Verify or expand the search:

Other Inimmune Corporation trials

Trials by the same sponsor.

NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06038279 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inimmune Corporation
Last refreshed: 16 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06038279.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing