Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000607875
Ethics application status
Approved
Date submitted
21/04/2021
Date registered
20/05/2021
Date last updated
22/02/2023
Date data sharing statement initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
INNA-051 intranasal safety and tolerability study
Scientific title
A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending, intranasal INNA-051 doses in healthy adults.
Secondary ID [1] 303706 0
Protocol INNA051-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 321129 0
Condition category
Condition code
Respiratory 318924 318924 0 0
Other respiratory disorders / diseases
Infection 319698 319698 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A: Single dose intra nasal INNA051. Cohort 1 will be 20mg, subsequent doses to be determined during the study based on safety data.
Part B and Part C: Intra nasal INNA051 administered on Day 1, Day 4, Day 7, and Day 10, or Day 1, Day 8, Day 15, and Day 22. Doses to be determined based on Part A data

Each participant will be included in one cohort only.

All doses will be administered by site staff.
Intervention code [1] 320014 0
Prevention
Intervention code [2] 320336 0
Treatment: Drugs
Comparator / control treatment
Part A: Single dose intranasal placebo (normal saline).
Part B and Part C: Intra nasal placebo administered on Day 1, Day 4, Day 7, and Day 10, or Day 1, Day 8, Day 15, and Day 22.

Each participant will be included in one cohort only.

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

Outcomes
Primary outcome [1] 327251 0
Safety and tolerability will be assessed by vital signs, clinical safety labs, electrocardiograms (ECGs), physical exam, nasal assessments, and adverse events.
Timepoint [1] 327251 0
Part A: Dosing on Day 1, daily in-patient monitoring for 48 hours plus follow up visit on Day 8
Part B: Dosing and daily in-patient monitoring for 48 hours post each dose, plus follow up visit 8 days after final dose.
Part C: Dosing and daily in-patient monitoring for 24 hours post each dose, plus follow up visit 8 days after final dose.
Secondary outcome [1] 394369 0
Changes from baseline in toll like receptor-induced safety blood biomarkers after single and multiple doses of INNA-051 and placebo.
Timepoint [1] 394369 0
Part A and Part B: Pre-dose and and at 6, 12, 24, and 48 hours post each dose.
Part C: Pre-dose and and at 6, 12, and 24 hours post each dose.
Secondary outcome [2] 394370 0
Changes in toll like receptor-induced nasal mucosal biomarkers after single and multiple doses of INNA-051 and placebo.
Timepoint [2] 394370 0
Part A and Part B: Pre-dose and and at 6, 12, 24, and 48 hours post each dose.
Part C: Pre-dose and and at 6, 12, and 24 hours post each dose.
Secondary outcome [3] 394374 0
Measurement of INNA-051 levels in plasma after single and multiple doses.
Timepoint [3] 394374 0
Part A, Part B, and Part C: On Day 1 within 10 minutes prior to Investigational Product administration and at 15 and 30 minutes and 1, 2, 4, 6, 8, 12, 18, and 24 hours post dose.
Part B and Part C: within 10 minutes prior to the final dose of Investigational Product and at 15 and 30 minutes and 1, 2, 4, 6, 8, 12, 18, and 24 hours post dose.

Eligibility
Key inclusion criteria
1. Healthy adults 18 to less than 65 years of age (Part A and Part B), or 65 to 85 years of age inclusive (Part C) at the time of providing written informed consent.
2. Agree to the contraception requirements specified in protocol
3. Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
4. Body weight at least 50 kg and body mass index (BMI) within the range 18 – 34.9 kg/m2 (inclusive).
5. Participants with screening forced expiratory volume in one second (FEV1) at least 80% of the predicted value.
6. Willing and able to comply with the study requirements.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject’s ability to participate in the study.
2. Clinically significant laboratory assessments at Screening or Day -1
3. Pregnant or breast feeding
4. Chronic tobacco use or vaping within 60 days prior to screening, and/or positive urine cotinine and/or exhaled carbon monoxide test at check-in.
5. Current diagnosis of asthma.
6. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
7. History within 30 days prior to informed consent of active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis
8. Participants with nasal symptoms of upper respiratory tract infection within the 3 weeks prior to screening or baseline. .
9. Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test.
10. Administration of any intranasal product within the 30 days prior to dosing.
11. Use of prescription or non-prescription drugs within 7 days prior to dosing, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety. NOTE: Part C participants on medications may be included if the medication has been stable for at least 6 weeks prior to screening and is expected to remain stable during the study period.
12. Positive drug test or alcohol breath test at screening or Day -1, and/or significant history of alcohol or drug abuse as defined in the protocol.
13. Received an investigational product within 30 days or 5 half-lives (whichever is longer) prior to baseline, or concurrent participation in other clinical trials. COVID-19 vaccines will not be exclusionary unless administered intranasally within the 30 days prior to dosing.
14. History of drug or other allergy that, in the opinion of the Investigator or Ena Respiratory’s Medical Monitor, contraindicates participation in this study.
15. Inability to communicate properly and/or understand the requirements of the study.
16. Institutionalised individuals.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
4/06/2021
Date of last participant enrolment
Anticipated
Actual
24/11/2021
Date of last data collection
Anticipated
Actual
22/12/2021
Sample size
Target
76
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308120 0
Commercial sector/Industry
Name [1] 308120 0
Ena Respiratory Pty Ltd
Country [1] 308120 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ena Respiratory Pty Ltd
Address
Level 9, 31 Queen St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 308876 0
None
Name [1] 308876 0
Address [1] 308876 0
Country [1] 308876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308106 0
Bellberry
Ethics committee address [1] 308106 0
Ethics committee country [1] 308106 0
Australia
Date submitted for ethics approval [1] 308106 0
30/04/2021
Approval date [1] 308106 0
24/05/2021
Ethics approval number [1] 308106 0

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

Contacts
Principal investigator
Name 109558 0
Dr Charlotte Lemech
Address 109558 0
Scientia Clinical Research
Bright Building, Level 5 & 6
Corner High Avoca St
Randwick NSW 2031
Country 109558 0
Australia
Phone 109558 0
+61 293 825 807
Fax 109558 0
Email 109558 0
charlotte.lemech@scientiaclinicalresearch.com.au
Contact person for public queries
Name 109559 0
Nicole Kruger
Address 109559 0
Ena Respiratory
Level 9, 31 Queen St
Melbourne VIC 3000
Country 109559 0
Australia
Phone 109559 0
+61 3 9657 0746
Fax 109559 0
Email 109559 0
nk@enarespiratory.com
Contact person for scientific queries
Name 109560 0
Francesca Mercuri
Address 109560 0
Ena Respiratory
Level 9, 31 Queen St
Melbourne VIC 3000
Country 109560 0
Australia
Phone 109560 0
+61 3 9657 0746
Fax 109560 0
Email 109560 0
fm@enarespiratory.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a phase 1 study in healthy volunteers to guide further development plans. Individual participant results are not useful to the participants or to others outside of the sponsor. Only aggregate data may be posted/published.


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.