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 range18 Years – 64 Years

SexALL

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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.
✕. 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.

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)

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

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