Testing INI-2004 for Allergic Rhinitis in Healthy Volunteers and Patients

A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.

This study is testing a new treatment for allergic rhinitis to see if it is safe and tolerable for both healthy people and those with ragweed allergies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Inimmune Corporation (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT06038279 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of INI-2004, a new treatment for allergic rhinitis, in both healthy volunteers and patients with a history of ragweed-induced allergic rhinitis. The study is divided into two phases: Phase I involves administering single ascending doses to healthy participants, while Phase Ib focuses on multiple ascending doses in patients who have tested positive for ragweed allergies. Participants will be randomly assigned to receive either the active drug or a placebo, with careful monitoring for safety and side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with a documented history of ragweed-induced allergic rhinitis who require pharmacotherapy.

Not a fit: Patients with hypersensitivity to the study drug or its components, or those currently undergoing treatment for allergic rhinitis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from allergic rhinitis, particularly those affected by ragweed pollen.

How similar studies have performed: While this approach is novel, similar studies targeting allergic rhinitis have shown promise in developing effective treatments.

Eligibility criteria

Inclusion Criteria (Phase 1):

1. Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1.
2. Female participants must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal.

Inclusion Criteria Phase Ib (Multiple Ascending Dose)

1. Minimum 2 year history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted) and a positive ragweed skin prick test reaction at Screening Visit.
2. Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit.
3. Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal.

Exclusion Criteria Phase I and Phase Ib (MAD):

1. Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
2. Current treatment or use of any prescription medication within 14 days prior to admission to the clinic on Day -1 of active seasonal and perennial allergic rhinitis, non-allergic rhinitis, rhinosinusitis, or asthma. This includes antihistamines, asthma preventers and relievers, nasal decongestants, IN corticosteroids, and immunotherapy or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, paracetamol and standard doses of multivitamins.
3. Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds, upper respiratory tract infection within 2 weeks prior to screening or first dose administration.
4. History of recurrent migraine headaches within 4 weeks prior to screening.
5. Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests.
6. Participant has donated blood or blood products within 3 months prior to first dose administration.
7. Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches.
8. Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation.

Where this trial is running

Melbourne, Victoria

• Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Tim Porter

Conditions Allergic Rhinitis Due to Weed Pollen; Allergic Rhinitis