Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000635561p
Ethics application status
Submitted, not yet approved
Date submitted
8/05/2024
Date registered
16/05/2024
Date last updated
16/05/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
INNA-051 dry powder safety and tolerability study
Scientific title
A randomised, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intranasal INNA-051 doses delivered via dry powder spray in adult volunteers aged 60 years or older
Secondary ID [1] 312074 0
Protocol INNA-051-HVT-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory infection 333700 0
Condition category
Condition code
Infection 330379 330379 0 0
Other infectious diseases
Respiratory 330482 330482 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: Single dose intra nasal INNA051 150 micrograms administered on Day 1.
Cohorts 2, 3, 4, and 5: Intra nasal INNA051 administered on Day 1, Day 8, and Day 15. Doses to be confirmed based on Cohort 1 data

Each cohort has 8 participants; 6 will receive INNA-051.

Each participant will be included in one cohort only.

All doses will be administered by site staff.
Intervention code [1] 328515 0
Prevention
Intervention code [2] 328606 0
Treatment: Drugs
Comparator / control treatment
Cohort 1: Single dose intra nasal placebo administered on Day 1.
Cohorts 2, 3, 4, and 5: Intra nasal placebo administered on Day 1, Day 8, and Day 15.

Each cohort has 8 participants; 2 will receive placebo. Placebo is a dry powder identical to the study drug but does not contain INNA-051

Each participant will be included in one cohort only.

All doses will be administered by site staff.
Control group
Placebo

Outcomes
Primary outcome [1] 338143 0
Safety of INNA-051 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 338143 0
From first dose of study product on Day 1 to End of Study (EoS) on Day 8 (Cohort 1) or Day 21 (Cohorts 2 to 5) post baseline
Primary outcome [2] 338144 0
Safety of INNA-051
Timepoint [2] 338144 0
Cohort 1: days 2, 3, and 8 post baseline compared to Day 1
Cohorts 2 - 5: days 2, 3, 7, 8 , 9, and on each of days 14 to 21 post baseline compared to Day 1
Primary outcome [3] 338145 0
Safety of INNA-051
Timepoint [3] 338145 0
Cohort 1: days 2 and 8 post baseline compared to Day 1
Cohorts 2 - 5: days 2, 9, 16 and 21 post baseline compared to Day 1
Secondary outcome [1] 434684 0
INNA-051 levels in plasma
Timepoint [1] 434684 0
Cohort 1: blood sample within 10 minutes prior to Investigational Product administration on Day 1 and at 5, 10, 15 and 30 minutes and 1, 2, 6, 12, and 24 hours post dose.
Cohorts 2 - 5: blood sample within 10 minutes prior to Investigational Product administration on Day 1, Day 8, and Day 15, and at 5, 10, 15 and 30 minutes and 1, 2, 6, 12, and 24 hours post each dose
Secondary outcome [2] 434685 0
Changes in nasal innate immunity gene expression after intra nasal doses of INNA-051 or placebo
Timepoint [2] 434685 0
All cohorts: Pre each dose and and at 6, 12, 24, and 48 hours post each dose.
Secondary outcome [3] 434686 0
Changes in peripheral blood cytokines after intra nasal doses of INNA-051 or placebo.
Timepoint [3] 434686 0
All cohorts: Pre each dose and and at 6 and 24 hours post each dose.

Eligibility
Key inclusion criteria
- Males and females 60 years of age or older
Without clinically defined unstable disease, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight 50 kg or above and body mass index (BMI) 18 to 34.9 kg/m2 (inclusive).
- Forced expiratory volume in one second (FEV1) at least 80% of the predicted value at Screening.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any significant disease or disorder which may put the subject at risk because of participation in the study, influence the results of the study or the participant’s ability to participate in the study.
- History or evidence of tachyarrhythmias, heart block, or ischemic changes.
- Clinically significant abnormal laboratory assessments
- Chronic tobacco use, chronic cannabis smoking, or chronic vaping.
- Nasal conditions likely to affect the outcome of the study, for example nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
- Active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis
- Upper respiratory tract infection or nasal symptoms

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26521 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 42562 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 316435 0
Commercial sector/Industry
Name [1] 316435 0
ENA Respiratory Pty Ltd
Country [1] 316435 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ENA Respiratory Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 318639 0
None
Name [1] 318639 0
Address [1] 318639 0
Country [1] 318639 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315227 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 315227 0
Ethics committee country [1] 315227 0
Australia
Date submitted for ethics approval [1] 315227 0
15/04/2024
Approval date [1] 315227 0
Ethics approval number [1] 315227 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134050 0
Dr Christopher Argent
Address 134050 0
Scientia Clinical Research Bright Building, Level 5 & 6 Corner High Avoca St Randwick NSW 2031
Country 134050 0
Australia
Phone 134050 0
+612 9382 5807
Fax 134050 0
Email 134050 0
[email protected]
Contact person for public queries
Name 134051 0
Nicole Kruger
Address 134051 0
Ena Respiratory Level 9, 31 Queen St Melbourne VIC 3000
Country 134051 0
Australia
Phone 134051 0
+613 9657 0700
Fax 134051 0
Email 134051 0
[email protected]
Contact person for scientific queries
Name 134052 0
Christophe Demaison
Address 134052 0
Ena Respiratory Level 9, 31 Queen St Melbourne VIC 3000
Country 134052 0
Australia
Phone 134052 0
+613 9657 0700
Fax 134052 0
Email 134052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.