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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04519788




Registration number
NCT04519788
Ethics application status
Date submitted
14/08/2020
Date registered
20/08/2020
Date last updated
19/01/2021

Titles & IDs
Public title
AT-301 Nasal Spray in Healthy Adults
Scientific title
A Double-blinded, Randomised, and Placebo-controlled Safety Study of AT-301 Nasal Spray in Healthy Adults
Secondary ID [1] 0 0
AT-301-AU-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT-301B
Treatment: Drugs - AT-301A

Active Comparator: AT-301B - AT-301B consists of edetate disodium, glyceryl monooleate, polysorbate 80, benzalkonium chloride, microcrystalline cellulose and sodium carboxymethylcellulose (vivapur), trisodium citrate dihydrate, and purified water (HCl to adjust pH to 5.0)

Placebo Comparator: AT-301A - AT-301A consists of sodium chloride, benzalkonium chloride and purified water (NaOH/HCl to adjust pH to 5.0)


Treatment: Drugs: AT-301B
Nasal Spray

Treatment: Drugs: AT-301A
Nasal Spray

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
cardiac, pulmonary and hemodynamic parameters using 12-lead ECG - incidence of abnormal ECG Change from baseline in clinical laboratory parameters
Change from baseline in vital signs parameters
Change from baseline in 12-lead ECGs
Change from baseline in physical examination findings including auscultation
Change from baseline in oxygen saturation
Timepoint [1] 0 0
from baseline through study completion, an average of 40 days
Primary outcome [2] 0 0
auscultation - incidence of abnormal sounds Change from baseline in clinical laboratory parameters
Change from baseline in vital signs parameters
Change from baseline in 12-lead ECGs
Change from baseline in physical examination findings including auscultation
Change from baseline in oxygen saturation
Timepoint [2] 0 0
from baseline through study completion, an average of 40 days
Primary outcome [3] 0 0
determination of oxygen saturation levels - Incidence of abnormal oxygen saturation Change from baseline in clinical laboratory parameters
Change from baseline in vital signs parameters
Change from baseline in 12-lead ECGs
Change from baseline in physical examination findings including auscultation
Change from baseline in oxygen saturation
Timepoint [3] 0 0
from baseline through study completion, an average of 40 days
Primary outcome [4] 0 0
haematology, coagulation and serum chemistry - incidence of abnormal ranges Change from baseline in clinical laboratory parameters
Change from baseline in vital signs parameters
Change from baseline in 12-lead ECGs
Change from baseline in physical examination findings including auscultation
Change from baseline in oxygen saturation
Timepoint [4] 0 0
from baseline through study completion, an average of 40 days
Primary outcome [5] 0 0
urinalysis - incidence of abnormal measures Change from baseline in clinical laboratory parameters
Change from baseline in vital signs parameters
Change from baseline in 12-lead ECGs
Change from baseline in physical examination findings including auscultation
Change from baseline in oxygen saturation
Timepoint [5] 0 0
from baseline through study completion, an average of 40 days
Secondary outcome [1] 0 0
Nasal Spray Attributes Questionnaire score - based on a scale of 0 to 6, for each immediate attribute assessed; 0 equals none, 3 equals severe for each question; lower scores have better outcome
Timepoint [1] 0 0
from baseline through study completion, an average of 40 days
Secondary outcome [2] 0 0
Incidence and severity of AE (bronchospasms) - AE monitoring
Timepoint [2] 0 0
from baseline through study completion, an average of 40 days

Eligibility
Key inclusion criteria
Must have given written informed consent before any study-related activities are carried
out and must be able to understand the full nature and purpose of the trial, including
possible risks and adverse effects 2. Adult males and females, 18 to 64 years of age
(inclusive) at the screening visit 3. Are non-smokers (including tobacco, e-cigarettes and
marijuana) for a minimum of 1 month prior to the screening visit. Non-smokers with a
significant history of smoking (> 5 pack years) are not eligible 4. Have a physically
normal nasal structure (minor septum deviation allowable) 5. Body mass index (BMI)
(calculated) within the range of 18 to 30 kg/m2 inclusive at the screening visit and prior
to dosing on Day 1 6. Medically healthy without clinically significant abnormalities in the
opinion of the investigator at the screening visit and prior to dosing on Day 1, including:

1. Physical examination without any clinically significant findings

2. Systolic blood pressure (BP) in the range of 90 to 140 mm Hg (inclusive) and diastolic
BP in the range of 50 to 90 mm Hg (inclusive) after at least 5 minutes in a seated
position

3. Heart rate (HR) in the range of 45 to 100 beats/min (inclusive) after at least 5
minutes rest in a semi-recumbent position

4. Normal body (tympanic) temperature (35.5 to 37.7°C, inclusive)

5. The 12-lead electrocardiogram (ECG), taken after the volunteer has been supine for at
least 5 minutes, must be within normal range (corrected QT interval [QTc] males =450
msec; females =470 msec) or with abnormalities that are not hazardous to the volunteer

6. No clinically significant findings in serum chemistry, haematology, coagulation and
urinalysis examinations (Note: assessed at screening only for eligibility) 7. Negative
cotinine, drug and alcohol tests at screening and prior to dosing on Day 1 8. Female
volunteers must:

a. Be of non-child-bearing potential i.e., have follicle-stimulating hormone levels >40
IU/L at screening and be surgically sterilized (hysterectomy, bilateral salpingectomy,
bilateral oophorectomy at least 6 weeks before the Screening visit) or postmenopausal
(where postmenopausal is defined as no menses for 12 months without an alternative medical
cause), or b. If of childbearing potential, must have a negative pregnancy test at
Screening (blood test) and before the first study drug administration (pre-dose Day 1 urine
test). They must agree not to attempt to become pregnant, must not donate ova, and must
agree to use a highly effective contraceptive method in addition to having their male
partner use a condom (if not surgically sterilised) for penile-vaginal intercourse from
signing consent until at least 30 days after the last dose of study therapy (Appendix 3) 9.
Male volunteers, if not surgically sterilised, must agree not to donate sperm and if
engaging in sexual intercourse with a female partner who could become pregnant, must agree
to use a condom in addition to having the female partner use a highly effective
contraceptive method (Appendix 3) from signing the consent form until at least 90 days
after the last dose of study therapy (Note: male volunteers are not required to use
contraception with a partner of the same sex) 10. Have suitable venous access for blood
sampling 11. Willing and able to comply with the requirements of the study protocol
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of the following based on self-report: of tuberculosis, asthma
(including childhood asthma), severe bronchial asthma, chronic obstructive pulmonary
disease, peptic ulcer or major pulmonary airway disease

2. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the
Investigator to affect assessment of the investigational product

3. Active hay fever, rhinitis or cold

4. History or presence of significant cardiovascular, hepatic, renal, haematological,
gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric
disease, including any acute illness or surgery within the past three months
determined by the PI to be clinically significant

5. Known allergy to any of the formula components

6. Current obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar
proteinosis and allergic alveolitis caused by lung tumour

7. Positive serum pregnancy test for women of childbearing potential at the Screening
visit or positive urine pregnancy test with confirmatory serum pregnancy test prior to
dosing on Day 1

8. Females who are breastfeeding

9. Liver function test results (i.e., aspartate aminotransferase [AST], alanine
aminotransferase [ALT], and gamma-glutamyl transferase [GGT]) and total bilirubin >
1.5 x fold above the upper limit of normal at the screening visit. Elevated total
bilirubin allowable if an isolated finding

10. Positive testing for active human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), hepatitis C virus (HCV) antibodies, at the screening visit

11. Use of any prescription or over-the-counter medication (including nasal medication,
herbal products, diet aids, and hormone supplements) within 7 days or 5 half-lives of
the medication (whichever is longer) prior to the first study drug administration,
except for contraceptives for female participants of childbearing potential and
occasional use of paracetamol

12. Donation of blood or plasma within 30 days prior to randomization, or loss of whole
blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood
transfusion within 1 year of study enrolment

13. Participation in another investigational clinical trial within 30 days or 5 half-lives
(whichever is longer) in the case of an investigational drug prior to the first study
drug administration

14. Any other condition or prior therapy, which, in the opinion of the Investigator, would
make the volunteer unsuitable for this study, including unable to cooperate fully with
the requirements of the study protocol or likely to be non-compliant with any study
requirements

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
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atossa Genetics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study.
The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed
by a multiple ascending dose (MAD) part (Part 2).
Trial website
https://clinicaltrials.gov/show/NCT04519788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Canny
Address 0 0
Bellberry Limited HREC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications