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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06038279




Registration number
NCT06038279
Ethics application status
Date submitted
31/07/2023
Date registered
14/09/2023
Date last updated
14/09/2023

Titles & IDs
Public title
Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
Scientific title
A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.
Secondary ID [1] 0 0
INI-2004-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis Due to Weed Pollen 0 0
Allergic Rhinitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INI-2004
Treatment: Drugs - Placebo

Experimental: Arm 1 (SAD)- INI-2004 Dose Cohort 1 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).

Experimental: Arm 2 (SAD)- INI-2004 Dose Cohort 2 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).

Experimental: Arm 3 (SAD)- INI-2004 Dose Cohort 3 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).

Experimental: Arm 4 (SAD)- INI-2004 Dose Cohort 4 - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).

Placebo comparator: Placebo - Healthy Participants will be enrolled and randomised to receive a single dose of INI-2004 or placebo intranasally (ratio 3:1 active: placebo).

Experimental: Arm 1 (MAD) - INI-2004 Dose Cohort 1 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.

Experimental: Arm 2 (MAD) -INI-2004 Dose Cohort 2 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.

Experimental: Arm 3 (MAD) - INI-2004 Dose Cohort 3 - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.

Placebo comparator: Placebo (MAD) - Participants with allergic rhinitis will be enrolled and randomised (ratio 3:1 active:placebo) to receive INI-2004 or placebo intranasally once per week for a total of 4 weeks.


Treatment: Drugs: INI-2004
INI-2004 (a toll-like receptor \[TLR\]4 agonist) liposomal formulation. INI-2004 is an intranasal (IN) TLR4 agonist that is targeted to prevent AR symptoms in subjects with seasonal AR.

Treatment: Drugs: Placebo
The Placebo for INI-2004 is a clear, colorless solution free of particles supplied in 10 mL glass vials with a 10 mL fill.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline, Day 1 then daily through to Day 7 End of Study Visit
Primary outcome [2] 0 0
Incidence, severity and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment after multiple ascending doses (MAD)
Timepoint [2] 0 0
Baseline = Day 0, Day 14, 21, 28, 35 through to Day 58 End of Study Visit
Primary outcome [3] 0 0
Number of Participants with a Change from baseline in Vital signs measurements after a single ascending Dose (SAD)
Timepoint [3] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [4] 0 0
Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses (MAD)
Timepoint [4] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [5] 0 0
Change from baseline in 12-lead electrocardiogram parameters after a single ascending Dose (SAD)
Timepoint [5] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [6] 0 0
Change from baseline in 12-lead electrocardiogram parameters after multiple ascending doses (MAD)
Timepoint [6] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [7] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Timepoint [7] 0 0
Baseline, Day 2 through to Day 7 End of Study Visit
Primary outcome [8] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Timepoint [8] 0 0
Baseline, Day 2 through to Day 7 End of Study Visit
Primary outcome [9] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after a single ascending Dose (SAD)
Timepoint [9] 0 0
Baseline, Day 2 through to Day 7 End of Study Visit
Primary outcome [10] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Timepoint [10] 0 0
Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Primary outcome [11] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Timepoint [11] 0 0
Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Primary outcome [12] 0 0
Number of Participants with a Change from baseline in Clinical laboratory results after multiple ascending doses (MAD)
Timepoint [12] 0 0
Baseline = Day 0, Day 14 and Day 58 End of Study Visit
Primary outcome [13] 0 0
Change from baseline in Nasal symptoms after a single ascending Dose (SAD)
Timepoint [13] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [14] 0 0
Change from baseline in Nasal symptoms after multiple ascending doses (MAD)
Timepoint [14] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [15] 0 0
Change from baseline in Nasal irritancy after a single ascending Dose (SAD)
Timepoint [15] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [16] 0 0
Change from baseline in Nasal irritancy after multiple ascending doses (MAD)
Timepoint [16] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [17] 0 0
Change from baseline in Spirometry after a single ascending Dose (SAD)
Timepoint [17] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [18] 0 0
Change from baseline in Spirometry after a single ascending Dose (SAD)
Timepoint [18] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [19] 0 0
Change from baseline in Spirometry after a single ascending Dose (SAD)
Timepoint [19] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [20] 0 0
Change from baseline in Spirometry after a single ascending Dose (SAD)
Timepoint [20] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [21] 0 0
Change from baseline in Spirometry after a single ascending Dose (SAD)
Timepoint [21] 0 0
Baseline, Day 1 through to Day 7 End of Study Visit
Primary outcome [22] 0 0
Change from baseline in Spirometry after multiple ascending doses (MAD)
Timepoint [22] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [23] 0 0
Change from baseline in Spirometry after multiple ascending doses (MAD)
Timepoint [23] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [24] 0 0
Change from baseline in Spirometry after multiple ascending doses (MAD)
Timepoint [24] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [25] 0 0
Change from baseline in Spirometry after multiple ascending doses (MAD)
Timepoint [25] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Primary outcome [26] 0 0
Change from baseline in Spirometry after multiple ascending doses (MAD)
Timepoint [26] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Secondary outcome [1] 0 0
Effectiveness of INI-2004 on nasal congestion will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Timepoint [1] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [2] 0 0
Effectiveness of INI-2004 on peak nasal inspiratory flow will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 14, 21, 23, 28, 35, 37, 51 and 58 compared to baseline (Day 0)
Timepoint [2] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [3] 0 0
Effectiveness of INI-2004 on nasal symptoms will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Timepoint [3] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [4] 0 0
Effectiveness of INI-2004 on nasal irritancy will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0)
Timepoint [4] 0 0
Baseline = Day 0 through to Day 58 End of Study Visit
Secondary outcome [5] 0 0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51, and 58 compared to baseline (Day 0) via PEF
Timepoint [5] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [6] 0 0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) Via FEV1
Timepoint [6] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [7] 0 0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FVC
Timepoint [7] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [8] 0 0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEV1/FVC ratio
Timepoint [8] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [9] 0 0
The effectiveness of INI-2004 on Spirometry will be assessed by response to the ragweed allergen challenge (Phase Ib [MAD] only) on Days 23, 37, 51 and 58 compared to baseline (Day 0) via FEF
Timepoint [9] 0 0
Baseline = Day 0 through to Day 58
Secondary outcome [10] 0 0
Single dose PK parameters: maximum observed concentration (Cmax)
Timepoint [10] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [11] 0 0
Single dose PK parameters: Time to Cmax (Tmax)
Timepoint [11] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [12] 0 0
Single dose PK parameters: Area under the concentration-time curve from time 0 to time t (AUC0-t)
Timepoint [12] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [13] 0 0
Single dose PK parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast)
Timepoint [13] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [14] 0 0
Single dose PK parameters: Half-life (t1/2)
Timepoint [14] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [15] 0 0
Single dose PK parameters: Clearance (Cl/f)
Timepoint [15] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [16] 0 0
Single dose PK parameters: Volume of distribution (Vz/f)
Timepoint [16] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [17] 0 0
Single dose PK parameters: Area under the drug concentration-time curve from time zero infinity (AUCinf)
Timepoint [17] 0 0
Day 1 pre dose, then at 15 and 30 mins post-dose, then 1, 2 and 4 hours post-dose, Day 2 at 24 hours post-dose.
Secondary outcome [18] 0 0
Multiple dose PK parameters: Drug concentrations from pre-dose to 4 hours post-dose on Days 14 and 35.
Timepoint [18] 0 0
Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Secondary outcome [19] 0 0
Multiple dose PK parameters: AUC0-4 on Days 14 and 35 (if data permits)
Timepoint [19] 0 0
Day 14 pre dose then 1, 2 and 4 hours post-dose, Day 35 pre dose then 1, 2 and 4 hours post-dose
Secondary outcome [20] 0 0
Multiple dose PK parameters: Post-dose urine drug concentration on Day 14.
Timepoint [20] 0 0
Urine to be collected at 0-2 hours post-dose interval on Day 14 only.
Secondary outcome [21] 0 0
Single dose PD parameters: Changes in cytokine levels in nasal secretions post-dose compared to baseline pre-dose.
Timepoint [21] 0 0
Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Secondary outcome [22] 0 0
Single dose PD parameters: Changes in cytokine levels in plasma post-dose compared to baseline pre-dose.
Timepoint [22] 0 0
Baseline Day 1 pre-dose then 4, 24 and 48 hours post-dose.
Secondary outcome [23] 0 0
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in nasal secretions following dose administration compared to baseline pre-dose.
Timepoint [23] 0 0
Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.
Secondary outcome [24] 0 0
Multiple dose PD parameters: Changes in concentrations of pro-inflammatory cytokines and nasal mediators in plasma following dose administration compared to baseline pre-dose.
Timepoint [24] 0 0
Baseline pre-dose on Day 14 and 35, post-dose Days 14 and 35.

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inimmune Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 (SAD) and Phase Ib multiple ascending dose (MAD).
Trial website
https://clinicaltrials.gov/study/NCT06038279
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
JonL. Ruckle
Address 0 0
Inimmune Corp
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tim Porter
Address 0 0
Country 0 0
Phone 0 0
+61 450992172
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06038279