CompletedPhase 1

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

Australia68 participantsStarted 2023-07-04

Plain-language 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 (SAD) and Phase Ib multiple ascending dose (MAD).

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after a single ascending Dose (SAD)

Timeframe: Baseline, Day 1 then daily through to Day 7 End of Study Visit

Timeframe: Baseline = Day 0, Day 14, 21, 28, 35 through to Day 58 End of Study Visit

Number of Participants with a Change from baseline in Vital signs measurements after a single ascending Dose (SAD)

Timeframe: Baseline, Day 1 through to Day 7 End of Study Visit

Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses (MAD)

Timeframe: Baseline = Day 0 through to Day 58 End of Study Visit

Change from baseline in 12-lead electrocardiogram parameters after a single ascending Dose (SAD)

Timeframe: Baseline, Day 1 through to Day 7 End of Study Visit

Change from baseline in 12-lead electrocardiogram parameters after multiple ascending doses (MAD)

Trial details

NCT IDNCT06038279

SponsorInimmune Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-05

View on ClinicalTrials.gov More Allergic Rhinitis Due to Weed Pollen trials