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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001187336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
19/08/2026
Date registered
Help: Date registered
24/09/2026
Date last updated
Help: Date last updated
24/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD) Safety, Pharmacokinetics and Immunogenicity Study of Nebulized IN-007 in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD) Safety, Pharmacokinetics and Immunogenicity Study of Nebulized IN-007 in Healthy Volunteers
Additional trial identifiers [1] 318199 0
IN-007-01
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Covid-19 343255 0
Condition category
Condition code
Infection 339367 339367 0 0
Other infectious diseases
Respiratory 339519 339519 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study drug IN-007 is provided as an aqueous solution for nebulization. Participants will inhale the study drug using a nebulizer over a period of 4-10 minutes of inhalation.
The study has 2 parts –
Part A has 2 cohorts and participants will receive either IN-007 or placebo. Dosing will start at 60 mg (single dose on Day 1) and subsequent dose for second cohort will be confirmed after approval from the Dose escalation committee (DEC). Maximum dose to not exceed 180mg.
Part B has 2 cohorts and participants will receive either IN-007 or placebo. Dosing will start at 40 mg (twice daily from Day 1 to Day 5) and subsequent dose for second cohort will be confirmed after approval from the Dose escalation committee (DEC). Maximum dose to not exceed 120mg (twice daily from Day 1 to Day 5).
Part B will commence after all participants in Part A have completed dosing. Part A participants will not be eligible for participation in Part B.
A Dose Escalation Committee (DEC) will review the safety data to advance from group to group, including from the SAD portion to the MAD portion.
Participants will be dosed as in-patients and adherence will be monitored by site staff.
Intervention code [1] 335096 0
Treatment: Drugs
Description of the comparator or control
Placebo - is a sterile, pyrogen-free, preservative-free, clear and colourless normal saline (0.9%) provided for nebulisation.
Control group
Placebo

Outcomes
Primary outcome [1] 346571 0
To evaluate the safety and tolerability of nebulized IN-007 in normal healthy volunteers. Safety and tolerability will be assessed as a composite primary outcome. This outcome is assessed for both SAD and MAD.
Timepoint [1] 346571 0
Adverse Events will be assessed at all visits from screening, everyday on Days -1, to 3, Day 5, 8, 15, 29 and 57 for SAD cohorts. Adverse Events will be assessed at all visits from screening, everyday on Days -1, to 6, Day 8, 10, 15, 29 and 62 for MAD cohorts.
Secondary outcome [1] 466432 0
To assess the systemic pharmacokinetics of IN-007 in serum and nasal fluids. This outcome is assessed for both SAD and MAD.
Timepoint [1] 466432 0
SAD: Nasopharyngeal swabs will be collected pre-dose (any time prior to dose administration) and post dose at 1hr and 12hrs. Blood samples will be collected pre-dose (any time prior to dose administration) and post dose at 12hrs, 24 hrs and 48hrs and once on Days 5, 8, 15, 29 & 57. MAD: Nasopharyngeal swabs will be collected Day 1 pre-dose (1 hour prior); Days 1 and 2 at 11 hrs post-dose 1 and 1 hr post-dose 2; Day 3 at 6 hrs post-dose 1 and 1 hr post-dose 2; Day 4 at 11 hrs post-dose 1 & 2; Day 5 at 6 hrs post-dose 1 and 11 hrs post-dose 2; Day 8 (72 hrs post-Day 5 dose 1).. Blood samples will be collected pre-dose (1 hour prior) and post dose at 11 hrs and 23 hrs on Day 1, once on Days 4, 6, 8, 10, 15, 29 and 62.
Secondary outcome [2] 466508 0
To assess Safety based on change in baseline in physical examination, vital signs, clinical laboratory parameters, Electrocardiogram (ECG), oxygen saturation (SpO2), Diffusing Capacity of the lungs for Carbon Monoxide (DLCO), and Forced expiratory volume in one second (FEV1). This outcome is assessed for both SAD and MAD.
Timepoint [2] 466508 0
All assessments will be conducted at Screening, Day -1 (except PE), Day 1 (except PE and DLCO) and end of study visits (Day 57 for SAD, Day 62 for MAD). Additionally - Physical exam will be conducted on Day 3 (SAD); Day6 (MAD) Vital signs will be measured on Days 3, 5,15 (SAD); Days 6,8,10,15 (MAD). SpO2 will be measured on Day 3 (SAD); Days 6,8,10 (MAD). ECG will be measured on Days 3, 5 (SAD); Day 6 (MAD). FEV1 will be measured on Days 3, 29 (SAD); Days 6,8,29 (MAD). DLCO will be measured on Day 5, 29 (SAD); Days 10,29 (MAD). Clinical lab parameters will be measured on SAD-Days 2, 5, 8, 15, 29; Days 6,10,29 (MAD)
Secondary outcome [3] 468076 0
To determine if anti-drug antibodies are induced against IN-007. This outcome is assessed for both SAD and MAD.
Timepoint [3] 468076 0
SAD: Blood samples are collected at pre-dose (anytime prior to dose administration) and Days 15, 29 and 57. Nasal samples will be collected pre-dose (anytime prior to dose administration), Day 15, 29 and 57. MAD: Blood samples are collected at pre-dose (1 hr prior) and Days 15, 29 and 62. Nasal samples will be collected pre-dose (anytime prior to dose administration), Day 15, 29 and 62.

Eligibility
Key inclusion criteria
Participants must:
1. Be aged 18-55 (inclusive) years.
2. Signed the informed consent form (ICF).
3. Non-smoker by history or light smoker by history (average less than 10 cigarettes per week).
4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) and no clinical significant results for Screening tests.
5. Negative test for Hepatitis B, C, HIV and Covid-19.
6. Able to successfully complete 4.5ml saline nebulisation at the Day -1 visit.
7. Body mass index (BMI) 18.0 - 32.0 (kg/m2) at screening visit
8. Female participants and capable of becoming pregnant, have a negative pregnancy test at Screening and Day -1 and must agree to use a highly effective method of contraception from one month prior to screening till 130 days after last dose of study drug.
9. Male participants must agree to wear condoms with sexual partner(s) of childbearing potential and their partners must agree to use a highly effective form of birth control from signing of consent form and for at least 190 days after last dose of study drug.
10. Be able and willing to comply with all study assessments and adhere to the protocol.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Participants must not:
1. Have known or suspected symptomatic viral infection within 14 days of first dose.
2. Have signs and/or symptoms of active upper respiratory or pulmonary infection or pulmonary inflammatory conditions within 14 days of first dose.
3. Have history of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo.
4. Have history of asthma.
5. Have currently active allergic rhinitis requiring sprays and/or inhaled medication or allergic dermatitis currently requiring medication at screening visit and within 7 days prior.
6. Be currently breastfeeding or planning to breast feed at any time during the study.
7. Have loss of whole blood of more than 500 mL within 30 days prior to enrolment, or receipt of a blood transfusion within 1 year of study enrolment.
8. Have a positive alcohol breathalyzer test and/or positive urine drug screen for substances of abuse at screening.
9. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study.

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)
An authorised, trained staff member from the site pharmacy will dispense the study drug according to pre-defined drug dispensing requirements. IN-007 or placebo will be packed in dosing bottles as per cohort. Study drug will be dispensed according to assigned randomisation number, and Study drug bottle dispensed should match the randomisation number. Code break envelopes will be produced by the statistician and will be retained at the study site in a secure, accessible location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned in a 3:1 ratio to receive IN-007 or placebo and will be documented in the study randomisation schedule. Sequence will be generated using permuted block randomisation.
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
16/12/2026
Actual
Date of last participant enrolment
Anticipated
28/02/2027
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 30006 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 46401 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 322765 0
Commercial sector/Industry
Name [1] 322765 0
Inhalon Biopharma, Inc.
Country [1] 322765 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Inhalon Biopharma, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 325686 0
Commercial sector/Industry
Name [1] 325686 0
Inhalon Biopharma, Pty Ltd
Address [1] 325686 0
Country [1] 325686 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321201 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 321201 0
Ethics committee country [1] 321201 0
Australia
Date submitted for ethics approval [1] 321201 0
02/09/2026
Approval date [1] 321201 0
Ethics approval number [1] 321201 0

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

Contacts
Principal investigator
Name 153002 0
Dr Philip Ryan
Address 153002 0
Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 153002 0
Australia
Phone 153002 0
+61 385939801
Fax 153002 0
Email 153002 0
[email protected]
Contact person for public queries
Name 153003 0
Inhalon Clinical Operations
Address 153003 0
Inhalon Biopharma, Inc. 5151 McCrimmon Parkway, Morrisville, NC 27560
Country 153003 0
United States of America
Phone 153003 0
+1 919 4381023
Fax 153003 0
Email 153003 0
[email protected]
Contact person for scientific queries
Name 153004 0
Inhalon Clinical Operations
Address 153004 0
Inhalon Biopharma, Inc. 5151 McCrimmon Parkway, Morrisville, NC 27560
Country 153004 0
United States of America
Phone 153004 0
+1 919 4381023
Fax 153004 0
Email 153004 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.