Status:
UNKNOWN
Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
Lead Sponsor:
Inimmune Corporation
Collaborating Sponsors:
Avance Clinical Pty Ltd.
Conditions:
Allergic Rhinitis Due to Weed Pollen
Allergic Rhinitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. Phase I (SAD) - Healthy Participants will be enrolled and randomised to...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Phase 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.
- 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)
- 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.
- Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit.
- Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal.
- Exclusion Criteria Phase I and Phase Ib (MAD):
- Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
- 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.
- 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.
- History of recurrent migraine headaches within 4 weeks prior to screening.
- Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests.
- Participant has donated blood or blood products within 3 months prior to first dose administration.
- Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches.
- Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation.
Exclusion
Key Trial Info
Start Date :
July 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06038279
Start Date
July 4 2023
End Date
November 1 2024
Last Update
September 14 2023
Active Locations (1)
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1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004