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Trial registered on ANZCTR


Registration number
ACTRN12621001235897
Ethics application status
Approved
Date submitted
10/08/2021
Date registered
13/09/2021
Date last updated
2/05/2022
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of an Inhaled Antibody in Healthy Volunteers
Scientific title
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of Nebulized IN-006 in Healthy Volunteers
Secondary ID [1] 304480 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 322314 0
Condition category
Condition code
Respiratory 319983 319983 0 0
Other respiratory disorders / diseases
Infection 319984 319984 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single centre, double-blind randomised placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of nebulised IN-006 in healthy volunteers.

The study will be enrolled in 3 cohorts. Subjects will only be allowed to enrol in one cohort.
1. 2 cohorts of single-ascending dose (SAD) cohorts: The first cohort will enrol 8 subjects, randomised to receive a single low dose of IN-006 or placebo. In the second cohort, 8 subjects will be randomised to receive a single high dose of IN-006 or placebo.
2. The last cohort is a multiple-dose (MD) cohort where 8 subjects will be randomised to receive a daily dose of IN-006 or placebo for 7 days. The dose will be determined from the safety data from SAD.

All subjects will receive IN-006 or placebo via a nebulizer which will be administered by the study site staff while in the clinic.

A Dose Escalation Committee (DEC) will review the safety data of the first 24 hours of SAD Cohort 1 before proceeding to SAD Cohort 2. A second DEC meeting will review safety data through Day 8 of Cohort 1 and the first 24 hours of SAD COhort 2 to determine the dose that will be administered in the MD cohort.
Intervention code [1] 320829 0
Treatment: Drugs
Comparator / control treatment
Placebo will be 0.9% normal saline and will be administered via a nebulizer by the study site staff in the identical manner as IN-006.
Control group
Placebo

Outcomes
Primary outcome [1] 327859 0
The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following a single dose of IN-006.

Safety and tolerability assessments will include vital signs (including FEV1 and SpO2), safety labs, ECG, and physical exams.
Timepoint [1] 327859 0
Vital signs including FEV1 and SpO2 will be collected at:
Screening, Day -1 (the day prior to dosing), Dosing Day 1, Day 2 at 24 hours post-dose, Day 4 (72 hr), Day 6 (120 hr), Day 8 (168 hr), Day 15, and Day 29 (End Of Study [EOS]). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.

Safety labs will be collected at:
Screening, Day -1 (the day prior to dosing), and post-dose on Day 2 (24 hours post-dose), Day 8 (168 hrs), and Day 29 (EOS).

ECGs will be collected at Screening, Day -1 (the day prior to dosing), Day 2 (24 hours post-dose), and Day 29 (EOS),

Complete physical exams will be completed at Screening, Day 2 (24 hours post-dose), and Day 29 (EOS), Symptom-directed exams may be conducted at any other time at the discretion of the investigator.
Primary outcome [2] 328198 0
The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following multiple doses of IN-006.

Safety and tolerability assessments will include vital signs (including FEV1 and SpO2), safety labs, ECG, and physical exams.
Timepoint [2] 328198 0
Vital signs including FEV1 and SpO2 will be collected at:
Screening, Day -1 (the day prior to dosing), Dosing Days 1 through 7, Day 8, Day 15, and Day 29 (EOS). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.

Safety labs will be collected at:
Screening, Day -1, and post-dose on Day 4 (72 hrs), Day 8 (168 hrs), Day 15, and Day 29.

ECGs will be collected at Screening, Day -1 (the day prior to dosing), and post-dose on Day 8, and Day 29 (EOS),

Complete physical exams will be completed at Screening, Day 8, and Day 29 (EOS), Symptom-directed exams may be conducted at any other time at the discretion of the investigator
Secondary outcome [1] 396795 0
To assess the pharmacokinetics of IN-006 levels in serum after a single dose of IN-006. PK parameters to be assessed will include Cmax, AUC, tmax , and t1/2.
Timepoint [1] 396795 0
On Day 1, predose and 30 minutes, 3 hours, and 12 hours post-dose, Day 2 (24 hours post-dose), and on Days 4, 6, 8, 15, and 29.
Secondary outcome [2] 396796 0
To assess the anti-drug-antibody levels induced against IN-006 after a single dose of IN-006. Samples will be analyzed using serum blood.
Timepoint [2] 396796 0
On Day 1 predose, and post-dose on Day 8 and Day 29.
Secondary outcome [3] 396797 0
To assess the pharmacokinetics of IN-006 in the respiratory tract (nasal fluids) after a single dose of IN-006. PK parameters to be assessed will include Cmax, AUC, tmax , and t1/2.
Timepoint [3] 396797 0
On Day 1, predose and 3 hours post-dose, Day 2 (24 hours post-dose); and on Days 4, 6, and 8.
Secondary outcome [4] 396798 0
To assess the pharmacokinetics of IN-006 levels in serum after multiple doses of IN-006. PK parameters to be assessed will include Cmax, AUC, tmax , and t1/2.
Timepoint [4] 396798 0
On Day 1 predose, 30 minutes, 3 hours, and 12 hours post-dose, Day 2 (24 hours post-dose of Day 1); D5 pre-dose, Day 7 at 30 minutes, 3 hours, and 12 hours post-dose, Day 8 (24 hours post-dose of Day 7); and on Days 10, 15, 22, and 29.
Secondary outcome [5] 396799 0
To assess the anti-drug-antibody levels induced against IN-006 after multiple doses of IN-006. Samples will be analyzed using serum blood.
Timepoint [5] 396799 0
At Day 1 predose, and post-dose on Days 15 and 29.
Secondary outcome [6] 396800 0
To assess the pharmacokinetics of IN-006 in the respiratory tract (nasal fluids) after multiple doses of IN-006. PK parameters to be assessed will include Cmax, AUC, tmax , and t1/2.
Timepoint [6] 396800 0
On Day 1 predose and 3 hours post-dose , Day 2 (24 hours post-dose of Day 1), Day 5 pre-dose, Day 7 at 3 hours post-dose, Day 8 (24 hours post-dose of Day 7), and on Days 10, 15, 22, and 29.

Eligibility
Key inclusion criteria
1. Male and female, age 18-55 years, inclusive.
2. Non-smoker or smokes on average less than or equal to 10 cigarettes per week
3. Woman participants must be non-pregnant and either surgically sterile, use an acceptable contraceptive method, or be post-menopausal
4. Male participants must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the partner must be surgically sterile or using an acceptable contraceptive method
5. Negative SARS-CoV-2 RT-PCR nasal swab during screening period
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known or suspected symptomatic viral infection within 14 days of dosing initiation.
2. Signs of active pulmonary infection or pulmonary inflammatory conditions within 14 days of dosing.
3. History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo.
4. History of previous administration of a monoclonal antibody or any inhaled biologic.
5. History of vaccination against SARS-CoV-2.
6. History of atopy or airway hyperresponsiveness.

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)
A computerised randomisation list will be created by an unbinded statistician or designee. Subjects will be randomised to receive IN-006 or placebo in a ratio of 3 to 1 respectively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In each cohort; 8 participants will be enrolled. Participants in each cohort will be randomized 3:1 to receive nebulized IN-006 or placebo.

Block randomization will also be used in the SAD portions of the study to allow randomization of a sentinel pair (1 active, 1 placebo) to be dosed first within each SAD dose group. The sentinel’s dosing and early post-dosing course will precede that of the remainder of the dose group, which will be randomized 1 placebo to 5 active; dosing of the remainder group will be done after the PI or DEC decides to proceed with dosing after an observation period of the sentinel group.
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
SAD and Multiple Dose cohorts.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Treatment effects will be examined using 2-sided tests at an alpha level of 0.05. No adjustment for multiplicity will be performed in this study. Details of the handling of dropouts or missing data will be fully described in the statistical analysis plan (SAP).
Additional exploratory analyses of the data will be conducted as deemed appropriate. The SAP will be finalized prior to database lock, and it will include a more technical and detailed description of the statistical analyses described in this section.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/09/2021
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
3/12/2021
Date of last data collection
Anticipated
Actual
29/12/2021
Sample size
Target
24
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19737 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 34376 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308841 0
Commercial sector/Industry
Name [1] 308841 0
Inhalon Biopharma, Inc.
Country [1] 308841 0
United States of America
Funding source category [2] 309162 0
Government body
Name [2] 309162 0
United States Department of Defense
Country [2] 309162 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Inhalon Biopharma, Inc.
Address
104 TW Alexander Drive
Building 20, Room 2021
Durham, NC 27709
Country
United States of America
Secondary sponsor category [1] 310059 0
Commercial sector/Industry
Name [1] 310059 0
Inhalon Biopharma Pty Ltd
Address [1] 310059 0
58 Gipps Street
Collingwood, VIC 3066
Country [1] 310059 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308748 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 308748 0
Ethics committee country [1] 308748 0
Australia
Date submitted for ethics approval [1] 308748 0
26/06/2021
Approval date [1] 308748 0
26/07/2021
Ethics approval number [1] 308748 0

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

Contacts
Principal investigator
Name 111754 0
Dr Jason Lickliter
Address 111754 0
Nucleus Network
Level 5, Burnet Tower, 89
Commercial Road, Melbourne,
VIC 3004
Country 111754 0
Australia
Phone 111754 0
+61 3 8593 9860
Fax 111754 0
Email 111754 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 111755 0
Taylor Kilfoil
Address 111755 0
InClin Pty Ltd
Suite 210, 25/29 Berry Street
Sydney, NSW 2060
Country 111755 0
Australia
Phone 111755 0
+61 408 880 403
Fax 111755 0
Email 111755 0
tkilfoil@inclin.com
Contact person for scientific queries
Name 111756 0
Taylor Kilfoil
Address 111756 0
InClin Pty Ltd
Suite 210, 25/29 Berry Street
Sydney, NSW 2060
Country 111756 0
Australia
Phone 111756 0
+61 408 880 403
Fax 111756 0
Email 111756 0
tkilfoil@inclin.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information developed during the conduct of this clinical study is considered confidential by the sponsor. This information may be disclosed as deemed necessary by the sponsor, except as required by law or regulation. Data from all subjects participating in the study will be pooled and analyzed by the sponsor or their designee. Individual participant data will not be published or made publicly available in a way that is identifiable, except as required by law or regulation.


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.