A Double-blinded, Randomised, and Placebo-controlled Safety Study of AT-301 Nasal Spray in Healthy Adults
- Conditions
- COVID-19Respiratory - Other respiratory disorders / diseasesInfection - Other infectious diseases
- Registration Number
- ACTRN12620000816954
- Lead Sponsor
- Atossa Therapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Healthy volunteers will be included in the study if they meet all of the following criteria:
1. 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
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:
a. Physical examination without any clinically significant findings
b. 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
c. Heart rate (HR) in the range of 45 to 100 beats/min (inclusive) after at least 5 minutes rest
in a semi-recumbent position
d. Normal body (tympanic) temperature (35.5.to 37.7°C, inclusive)
e. 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 less than
or equal to 450 msec; females less than or equal to 470 msec) or with abnormalities that
are not hazardous to the volunteer according to the opinion of the Investigator
f. No clinically significant findings in serum chemistry, haematology, coagulation and
urinalysis examinations as judged by the Investigator at screening
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 2
forms of highly effective contraceptive method for penile-vaginal intercourse from
signing consent until at least 30 days after the last dose of study therapy
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 from signing the consent form until at least 64 days after the last
dose of study therapy
10. Have suitable venous access for blood sampling
11. Willing and able to comply with the requirements of the study protocol
Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening or prior to dosing on Day 1:
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 relevant
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 herbal products, diet
aids, and hormone supplements) within 10 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 60 days or 5 half-lives
(whichever is longer) in the case of an investigational drug prior to the first 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method