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

Launched by INIMMUNE CORPORATION · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INI-2004, which is being tested to see how well it works for people with allergic rhinitis, particularly those who are allergic to ragweed pollen. The study is being conducted in two parts: the first part will involve giving a single dose of the treatment to healthy volunteers, while the second part will involve giving multiple doses to individuals who have a history of ragweed allergies. The trial is currently recruiting participants aged between 18 and 65, and both men and women can join as long as certain health criteria are met.

To participate in this trial, individuals must not have any serious health issues and should not be taking certain medications that could interfere with the study. Women who want to join should not be able to become pregnant, either because they have had surgery or are past menopause. Participants will need to avoid caffeine for 24 hours before their clinic visits, and they should not have any nasal problems or recent infections. Those who join the study will receive either the new treatment or a placebo (a harmless, inactive substance) in a controlled setting, where their health will be carefully monitored. This is a great opportunity to help advance research in allergy treatments while contributing to your own health knowledge!

Gender

ALL

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.